Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3126 | Pemziviptadil (PB1046) Wiki | 0.25 |
| drug794 | COVID visitation restrictions Wiki | 0.25 |
| drug1154 | Conventional CPR training Wiki | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1722 | Furosemide Injection Solution for subcutaneous administration (80 mg) Wiki | 0.25 |
| drug1723 | Furosemide Injection, USP Wiki | 0.25 |
| drug1404 | ECG from handheld device Wiki | 0.25 |
| drug3572 | Random Donor Plasma Wiki | 0.25 |
| drug28 | 12 weeks of bicycle exercise Wiki | 0.25 |
| drug5302 | web-based COMPASS intervention Wiki | 0.25 |
| drug3134 | Performance of WHEELS-I in promoting DASH/SRD adoption Wiki | 0.25 |
| drug2966 | Online real-time feedback video-based CPR training without quality measurement Wiki | 0.25 |
| drug3997 | Skin biopsy Wiki | 0.25 |
| drug176 | AZD3427 Wiki | 0.25 |
| drug2967 | Online real-time quality measurement and feedback video-based CPR training Wiki | 0.25 |
| drug1412 | EHR-based Clinician Jumpstart Wiki | 0.25 |
| drug2893 | Nutrition education Wiki | 0.25 |
| drug4305 | Tele-medicine platform Wiki | 0.25 |
| drug2393 | Low Dose (10 mg) Control Wiki | 0.25 |
| drug1190 | Covid-19 PCR , IGM Wiki | 0.25 |
| drug1457 | Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Wiki | 0.25 |
| drug189 | AZD9977 Wiki | 0.18 |
| drug72 | 50 mg/mL Virazole Wiki | 0.18 |
| drug1141 | Convalescent Plasma Transfusion Wiki | 0.18 |
| drug319 | Angiotensin-(1-7) Wiki | 0.18 |
| drug26 | 100 mg/mL Virazole Wiki | 0.18 |
| drug4192 | Supportive Care Wiki | 0.14 |
| drug1238 | DWRX2003 Wiki | 0.14 |
| drug1569 | Exercise program Wiki | 0.14 |
| drug1248 | Dapagliflozin Wiki | 0.13 |
| drug663 | Blood sampling Wiki | 0.09 |
| drug4692 | Vitamin D Wiki | 0.08 |
| drug3195 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D054143 | Heart Failure, Systolic NIH | 0.35 |
| D011660 | Pulmonary Heart Disease NIH | 0.25 |
| D002561 | Cerebrovascular Disorders NIH | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D019462 | Syncope, Vasovagal NIH | 0.25 |
| D013575 | Syncope NIH | 0.25 |
| D054144 | Heart Failure, Diastolic NIH | 0.25 |
| D013616 | Tachycardia, Sinus NIH | 0.25 |
| D054058 | Acute Coronary Syndrome NIH | 0.20 |
| D003327 | Coronary Disease NIH | 0.19 |
| D013896 | Thoracic Diseases NIH | 0.18 |
| D000787 | Angina Pectoris NIH | 0.18 |
| D007022 | Hypotension NIH | 0.18 |
| D000075902 | Clinical Deterioration NIH | 0.18 |
| D002546 | Ischemic Attack, Transient NIH | 0.18 |
| D002318 | Cardiovascular Diseases NIH | 0.16 |
| D016491 | Peripheral Vascular Diseases NIH | 0.14 |
| D011654 | Pulmonary Edema NIH | 0.14 |
| D015673 | Fatigue Syndrome, Chronic NIH | 0.14 |
| D013610 | Tachycardia NIH | 0.14 |
| D006331 | Heart Diseases NIH | 0.13 |
| D016584 | Panic Disorder NIH | 0.13 |
| D008103 | Liver Cirrhosis, NIH | 0.13 |
| D058729 | Peripheral Arterial Disease NIH | 0.13 |
| D001281 | Atrial Fibrillation NIH | 0.13 |
| D014652 | Vascular Diseases NIH | 0.13 |
| D007674 | Kidney Diseases NIH | 0.12 |
| D005356 | Fibromyalgia NIH | 0.11 |
| D009203 | Myocardial Ischemia NIH | 0.11 |
| D003693 | Delirium NIH | 0.10 |
| D007676 | Kidney Failure, Chronic NIH | 0.10 |
| D024821 | Metabolic Syndrome NIH | 0.09 |
| D009362 | Neoplasm Metastasis NIH | 0.09 |
| D008171 | Lung Diseases, NIH | 0.09 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.08 |
| D003324 | Coronary Artery Disease NIH | 0.08 |
| D051437 | Renal Insufficiency, NIH | 0.08 |
| D000073496 | Frailty NIH | 0.08 |
| D051436 | Renal Insufficiency, Chronic NIH | 0.08 |
| D013577 | Syndrome NIH | 0.07 |
| D017563 | Lung Diseases, Interstitial NIH | 0.06 |
| D002908 | Chronic Disease NIH | 0.06 |
| D008175 | Lung Neoplasms NIH | 0.06 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.06 |
| D007249 | Inflammation NIH | 0.04 |
| D003866 | Depressive Disorder NIH | 0.04 |
| D009369 | Neoplasms, NIH | 0.04 |
| D001008 | Anxiety Disorders NIH | 0.03 |
| D016638 | Critical Illness NIH | 0.03 |
| D003863 | Depression, NIH | 0.03 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.02 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
| D011014 | Pneumonia NIH | 0.01 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001635 | Congestive heart failure HPO | 1.00 |
| HP:0012668 | Vasovagal syncope HPO | 0.25 |
| HP:0011703 | Sinus tachycardia HPO | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001279 | Syncope HPO | 0.25 |
| HP:0001648 | Cor pulmonale HPO | 0.25 |
| HP:0001681 | Angina pectoris HPO | 0.18 |
| HP:0002615 | Hypotension HPO | 0.18 |
| HP:0002326 | Transient ischemic attack HPO | 0.18 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.16 |
| HP:0001649 | Tachycardia HPO | 0.14 |
| HP:0100598 | Pulmonary edema HPO | 0.14 |
| HP:0004757 | Paroxysmal atrial fibrillation HPO | 0.13 |
| HP:0001395 | Hepatic fibrosis HPO | 0.13 |
| HP:0000077 | Abnormality of the kidney HPO | 0.12 |
| HP:0001658 | Myocardial infarction HPO | 0.11 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.09 |
| HP:0002088 | Abnormal lung morphology HPO | 0.09 |
| HP:0000083 | Renal insufficiency HPO | 0.08 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.08 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.08 |
| HP:0012622 | Chronic kidney disease HPO | 0.08 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.06 |
| HP:0100526 | Neoplasm of the lung HPO | 0.06 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.06 |
| HP:0000716 | Depressivity HPO | 0.04 |
| HP:0002664 | Neoplasm HPO | 0.04 |
| HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 16 clinical trials
The essential arterial hypotension and allostasis registry is a prospective, observational research that has the purpose of demonstrating that essential blood pressure (BP) disorders and the associated comorbidities are a result of the inappropriate allostatic response to daily life stress. This required a functioning brain orchestrating the evaluation of the threat and choosing the response, this is a mind-mediated phenomenon. If the response is excessive it contributes to high BP, if deficient to low BP, and the BP itself will identify the allostatic pattern, which in turn will play an important role in the development of the comorbidities. To do so, consecutive patients of any age and gender that visit a cardiologist's office in Medellin, Colombia, are recruited. Individuals are classified according to their arterial BP and allostasis and follow them in time to see what kind of diseases develops the most (including BP) in the follow up according to the categorization of the characteristic chosen and after adjustment for confounder's variables. In addition, stress events with their date are registered. HYPOTHESIS The causes of the diseases are multifactorial. Physical, biochemical, psychological, social, and cultural dimensions of development dynamically interact to shape the health development process. A person´s health depends on their: 1. Biological and physiologic systems 2. External and internal environment (a) physical, b) internal behavioural and arousal state as registered by the brain. 3. Their interaction. The allostatic mechanisms to the internal and external stressors (allostatic load) involves a network composed by: 1. Functional systems; mediated by: 1. The Autonomic Nervous System 2. The endocrine system 3. The immune system 2. Structural changes: whenever the internal and/or external stressors are long lasting and/or strength enough, they may induce changes in: 1. Epigenetic, endophenotypes, polyphenism. 2. Plasticity 3. The interaction between a) and b). The network response do not affect exclusively the BP, propitiating the development of comorbidities, which may prompt strategies for prevention, recognition and ultimately, treatment. The allostatic model defines health as a state of responsiveness. The concept of psycho-biotype: The allostasis is the result of both: biological (allostasis) and psychological (psychostasis) abilities. It is proposed that both components behave in similar direction and magnitude. Immune disorders may be associated with the development of cancer. High BP population has a higher sympathetic and lower vagal tone, this has been associated with a decrease in the immune´s system function. Resources and energy depletion: Terms like weathering have been used to describe how exposures to different allostatic loads gradually scrape away at the protective coating that keeps people healthy. It is postulated that High BP individuals have more resources and energy.
Description: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality
Measure: Relationship between Blood pressure group and comorbidities Time: A 7-year prospective studyDescription: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality
Measure: Relationship between adaptability group and comorbidities Time: A 7-year prospective studyDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, and others. Cardiovascular mortality Total mortality
Measure: Relationship between blood pressure group, adaptability group and comorbidities Time: A 7-year prospective studyDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, homoeostasis model assessment (HOMA), total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: HR; PR interval, QRS complex, cQT interval Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.
Measure: Relationship between blood pressure group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) Time: A 7-year prospective studyDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.
Measure: Relationship between blood pressure group, adaptability group, habits anthropometric, metabolic, endocrine, electrocardiographic, Holter, ambulatory arterial blood pressure monitoring. Time: A 7-year prospective studyDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: 1) Hyper adaptable, 2) normal adaptability and 3) hypo adaptable. Habits: smoke and drink, exercise Anthropometric variables: Body mass index, waist, hip Metabolic and other variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides; thyrotropine, Holter variables: HR, standard deviation of NN intervals (SDNN) and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.
Measure: For metabolic disorders what it matters the most: the anthropometric variables vs blood pressure group vs adaptability group Time: A 7-year prospective studyDescription: Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Habits: smoke and drink Anthropometric variables: Body mass index, waist, hip Metabolic variables: Fasting glucose, 2 hs postprandial plasma glucose, insulin plasma levels, HOMA, total cholesterol, LDL, HDL, triglycerides. Endocrine variables: plasma cortisol, free cortisol in 24 hs. urine, epinephrine, norepinephrine, metanephrines, vanilmandelic acid, ACTH, aldosterone, renin, thyrotropine, free thyroxine, triiodothyronine, testosterone Electrocardiogram: PR interval, QRS complex, Heart rate, cQT interval Holter variables: HR, SDNN and sympathovagal balance, at day, night and 24 hs. ABPM: Systolic, diastolic, and heart rate, at day, night and 24 hs., BP matinal surge.
Measure: Relationship between adaptability group, habits and anthropometric, metabolic, endocrine, Electrocardiogram, Holter, ambulatory blood pressure monitoring (ABPM) Time: A 7-year prospective studyDescription: Clinical syncope characteristics (age of first syncope, number of syncope episodes, trauma, duration, clinical score, convulse, sphincter relaxation, etc.) Syncope cause Blood pressure group Adaptability group Prognosis
Measure: Syncope Registry Time: Up 100 weeksDescription: TTT protocol: describe the protocol, the time at positive response, nitroglycerine use, autonomic and hemodynamic variables. TTT outcome for syncope: positive or negative TTT other outcomes: 1) Chronotropic incompetence, 2) arterial orthostatic hypotension, 3) carotid hypersensitivity, 4) POTS, 5) IST The relationship between TTT results and Clinical score for syncope in regard to: syncope behaviour and other orthostatic intolerance entities, symptoms and comorbidities. The relationship between neurally mediated syncope response at the TTT and comorbidities.
Measure: Tilt table testing (TTT) registry Time: Up to 100 weeksDescription: EPS variables: AH, AV, CL, sino atrial conduction time (SACT), sinus node recovery time (SNRT), corrected sinus node recovery time (CSNRT), response to Isoproterenol, intrinsic heart rate Diagnosis: control, sick sinus syndrome, IST, chronotropic incompetence at the TTT HR at the ECG HR at the Holter monitoring HR at the TTT HRV at the Holter monitoring Syncope, cardiac or neurally mediated HR at the physical treadmill test Relationship with the blood pressure group Relationship with the adaptability group
Measure: Sinus node function at the electrophysiological study (EPS) Time: Up to 100 weeksDescription: Define how the blood pressure group and/or the adaptability group may add to the already known and include in this registry, in the diagnosis of cardiovascular complications as coronary artery disease, cerebrovascular disease, peripheral artery disease, nephropathy.
Measure: Score for coronary artery disease Time: Up to 200 weeksDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Comorbidities: As describe in the protocol, as a summary: 1) cardiovascular, 2) metabolic, 3) Endocrine, 4) psychiatric disorders: depression and panic disorder, 5) orthostatic intolerance: neurally mediated syncope, vasovagal syncope, inappropriate sinus tachycardia, Postural orthostatic syndrome, carotid sinus hypersensitivity; 6) others: chronic fatigue syndrome, fibromyalgia, arthritis, autoimmune diseases, pulmonary thromboembolism, OSA (obstructive sleep apnea), Alzheimer disease, Parkinson disease, others dementias, epilepsia, nephropathies, COPD, and others. Mortality
Measure: Neurally Mediated Syncope: further of the transient lost of consciousness (TLC) Time: A 7-year prospective studyDescription: Blood pressure group: 1) Essential arterial hypotension, 2) normotension and 3) Essential arterial hypertension. Adaptability group: Hyper adaptable, normal adaptability, hypo adaptable. Psychiatric variables: Big Five Questionary (BFQ) for personality. Modify of the Coping Scale (Scale of modified coping strategies) Zung questionary for depression and anxiety MINI in those patients with moderate or severe depression and/or anxiety at the Zung questionary
Measure: Psychobiotype: relationship between biological and psychological variables Time: Up to 100 weeksDescription: High sodium intake in the diet is recognized as a risk factor for hypertension development. Essential hypotension population is advised to increase the sodium (at least 10 grams a day) and water intake (at least 2 liters a day), or as much as possible, several have taken Fludrocortisone (is not a exclusion criteria). Normal blood pressure population are advised to have a normal or low sodium intake. Physical exercise is recommended in both groups. This registry is a good opportunity to test how important sodium diet is to induce hypertension, or if by the contrary adaptability could prevail over high sodium intake in this registry. Blood pressure groups: essential hypotension and normotension and those with new essential hypertension. Adaptability groups. The results will be adjusted for age, gender and BMI.
Measure: The role of high sodium intake in the development of essential hypertension. Comparison between essential hypotension (high sodium intake) vs normotension population (normal or low sodium intake) in the follow-up. Time: 4 yearsDescription: Consistent bradycardia in the ECG at the office and normal HR in the holter monitoring or the contrary. There are patients with complaints that may be attributed to bradycardia, low blood pressure, hypothyroidism, or other entities. Some patients very often have bradycardia in the ECG taken in the office and normal HR in the 24 Holter monitoring, the opposite is also possible. Patients with bradycardia (without medication or physiological condition as exersice affecting heart rate) in at least 2 ECG (less 60 bpm) and at least 2 Holter monitoring will be analyzed, Other variables to consider are: Age, gender, blood pressure group, adaptability group, maximum HR in the treadmill test, white coat or masked hypertension, Tilt-Table-test result or syncope cause, Electrophysiological study if available. The acknowledge of this phenomenon could have clinical implications in the diagnosis of sick sinus syndrome and physiopathological ones.
Measure: White coat effect in the heart rate or masked bradycardia. Time: 1 yearDescription: Bradycardia is the classical presentation form for sinus node dysfunction, mainly when associated with symptoms. Chronotropic incompetence is also a manifestation. Absence of medications with effects on the heart rate (HR) must be ruled out. Variables HR at the ECG, Holter monitoring, stress text, and at the physical examination previous to pacemaker implantation, Electrophysiological study (EPS): Basic cycle length, Sino-atrial conduction time, Sinus node recovery time, Corrected sinus node recovery time, Intrinsic HR when available 3. Pacemaker variables: HR at day and night or rest time Percentage of stimulation in A and V chambers 4. Syncope: Clinical characteriscs and clinical score Tilt table test results Trans Thoracic Echocardiogram in rest and or stress text Hypothesis: patients with ANSD will start to decrease the percentage atrial stimulation.
Measure: Reversible Bradycardia Mimicking Sinus Node Dysfunction as a Manifestation of Subacute Autonomic Nervous System Dysfunction (ANSD). Time: 2 yearsDescription: A non invasive, beat to beat BP monitoring, with the ability to measure BP, HR, Cardiac Output and Systemic Vascular Resistance (SVR) was started to use in the EHAR registry since May 2017. A description of this variables in the three BP groups will be collected in the data base (DB). This will allow to characterize whether SVR and/or CO maintain BP. Until now BP levels are related with prognosis. In the prognosis model SVR and CO will be add them to know what matter the most: BP levels, SVR and/or CO? In the EHAR registry a collection of the variables recognized as a risk factor for several comorbidities are available to adjust in multivariable analysis.
Measure: Description of the blood pressure hemodynamic profile at a medical office and their prognostic implications. Time: Three yearsTens of thousands of Veterans have heart failure with preserved ejection fraction (HFpEF), and suffer poor quality of life, frequent hospitalizations, and high death rates. Older Veterans and those with high blood pressure, obesity, and the metabolic syndrome (abnormal cholesterol and resistance to insulin's effects) are particularly at risk for HFpEF. However, it is not clear why only some Veterans in this risk group eventually develop HFpEF. Extensive information from experimental animal models and some human studies suggests that dietary patterns in vulnerable 'salt-sensitive' people could contribute to the risk for HFpEF. Reducing salt intake and increasing overall dietary quality in at-risk Veterans could prevent heart and blood vessel damage that ultimately leads to HFpEF. Reducing the development of HFpEF, which currently has no definitive treatment, is highly relevant to the VA's mission to emphasize prevention of disease and population health.
Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Left ventricular mass indexed to height
Measure: Left ventricular mass index Time: Phase 2 of study, change from baseline to 6 monthsDescription: Ventricular stiffness k, by Parametrized Diastolic Formalism analysis
Measure: Ventricular stiffness Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global longitudinal left ventricular strain, a sensitive measure of ventricular systolic function
Measure: Global longitudinal left ventricular strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Global left atrial strain, a novel measure of atrial function
Measure: Global left atrial strain Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Velocity of pulse wave traveling between carotid and femoral artery; validated measure of arterial stiffness
Measure: Carotid-femoral pulse wave velocity Time: Phase 2 of study, change from baseline to 6 monthsDescription: Left atrial volume by 3D echocardiography
Measure: Left atrial volume Time: Phase 2 of study, change from baseline to 6 monthsDescription: Change in 24-hour mean of >= 8 mmHg will define the salt-sensitive blood pressure phenotype
Measure: Salt-sensitivity phenotype Time: Phase 1 of study, change from baseline at the end of week 2 and week 4Description: Measure of dietary sodium intake
Measure: 24-hour urinary sodium excretion Time: Phase 2 of study, change from baseline to 6 monthsDescription: Sodium-restricted DASH diet score on Food Frequency Questionnaire, measured by complete or partial adherence to 9 dietary domains
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, change from baseline to 6 monthsDescription: Analysis of 3-day food diaries by a Registered Dietitian, utilizing the Nutrition Data System for Research
Measure: Sodium-restricted DASH diet adherence Time: Phase 2 of study, months 1 and 6The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationDescription: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationManagement of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus. Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found. The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation). The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.
Description: Development of an electronic (e-HEALTH) framework structure for management of patients with known cardiovascular disease in COVID19 pandemic social context
Measure: Providing a special electronic platform (e-health) for remote managing cardiovascular outpatients Time: 6 monthsDescription: patients come into direct contact with the case coordinator, who provides ongoing assistance, including for connecting to devices that ensure real-time data transmission and directing to specialist teams that establish stage diagnosis and management / therapy behavior (including adjustment). doses, decisions to discontinue medication or to add medication);
Measure: Number of patients included in this platform Time: 6 monthsDescription: Will be the number of sessions per patient multiplied with the number of patients included
Measure: Number of consultations/sessions given Time: 6 monthsThe proposed study aims to compare the pharmacokinetics and bioavailability of intravenous and subcutaneous Furosemide. Although these regimens are not intended to be bioequivalent, they are both expected to achieve therapeutic plasma levels and induce effective diuresis. The test formulation in this study is a buffered solution, Furosemide Injection Solution at 30 mg/mL at pH 7.4 (range 7.0 to 7.8) and is intended for SC injection according to the instructions in the protocol. A commercial formulation of Furosemide Injection, USP will serve as the reference drug in this study, which will be administered by IV bolus. It contains furosemide 10 mg/mL in solution at alkaline pH of 8.0 to 9.3 and is marketed for IV and IM injection. The primary objective of the study is to estimate the absolute bioavailability of furosemide administered by subcutaneous infusion compared with an equivalent dose of furosemide administered by IV bolus administration.
Description: Maximum plasma furosemide concentration after administration by subcutaneous infusion or IV bolus
Measure: Pharmacokinetic - Cmax Time: 0 to 24 hoursDescription: Area under the concentration versus time curve (AUC) from time 0 to the last measurable plasma furosemide concentration after administration by subcutaneous infusion or IV bolus
Measure: Pharmacokinetic - AUClast Time: 0 to 24 hoursDescription: AUC from time 0 to infinity for plasma furosemide after administration by subcutaneous infusion or IV bolus
Measure: Pharmacokinetic - AUCinf Time: 0 to 24 hoursDescription: Total collected urine volume after furosemide administration by subcutaneous infusion or IV bolus
Measure: Pharmacodynamic - Diuresis Time: 0 to 8 hoursDescription: Total collected urine volume after furosemide administration by subcutaneous infusion or IV bolus
Measure: Pharmacodynamic - Diuresis Time: 0 to 24 hoursDescription: Total sodium concentration in urine after furosemide administration by subcutaneous infusion or IV bolus
Measure: Pharmacodynamic - Natriuresis Time: 0 to 8 hoursDescription: Total sodium concentration in urine after furosemide administration by subcutaneous infusion or IV bolus
Measure: Pharmacodynamic - Natriuresis Time: 0 to 24 hoursBackground: Coronavirus disease (COVID-19) is a tremendous challenge the modern world has never seen before and is overwhelming the capacities of healthcare systems worldwide. Patients with cardiovascular diseases, heart failure in particular, and cardiovascular risk factors seem to be at a very high risk if affected by COVID-19 - and vice versa there are more and more reports of cardiac manifestations with the viral disease. Aim: The purpose of the study is to characterise the clinical course of adult inpatients with COVID-19 and concomitant cardiovascular affection in a worldwide, multicentre PCHF registry. Methods: Retrospective and prospective data analysis. Data on demographic, clinical, selected laboratory, electrocardiography and echocardiography parameters, treatment and outcome will be collected. The principal investigator provides dedicated electronic case report form. The primary outcome is in-hospital mortality. The secondary endpoints will be ICU length of stay, hospital length of stay, the need and duration of invasive mechanical ventilation, cardiovascular hospitalisation after 3 and 6 months from index hospitalisation, all-cause and cardiovascular mortality after 3 and 6 months from index hospitalisation.
Description: All-cause and cardiovascular mortality during index hospitalization.
Measure: In-hospital mortality. Time: Hospitalization period, assessed up to 30 daysDescription: The duration of hospitalization on the intensive care unit.
Measure: The length of stay in the intensive care unit. Time: Hospitalization period in the ICU, assessed up to 30 daysDescription: The total length of stay in the hospital.
Measure: The duration of hospitalization. Time: Hospitalization period, assessed up to 30 daysThe role of ECMO in the treatment of patients with severe COVID-19 (Acute Respiratory Distress Syndrome (ARDS) and/or acute refractory heart failure) is not yet known. The present study will aim to report the results of the ECMO management of the most severe forms of COVID-19 through the first French ECMO registry.
Description: Hospital mortality
Measure: Hospital mortality Time: up to 90 daysDescription: Mortality Day 28
Measure: Mortality Day 28 Time: Day 28Description: Mortality Day 90
Measure: Mortality Day 90 Time: Day 90Description: Ventilator-free days
Measure: Ventilator-free days Time: Day 28Description: ICU-free days
Measure: Intensive care unit-free days Time: Day 28Description: Hospital-free days
Measure: Hospital-free days Time: Day 28This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of pemziviptadil (PB1046) by improving the clinical outcomes in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy
Measure: Reduction in hospital resource utilization defined as a composite of: total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy Time: 28 daysThe COVID-19 attack is polymorphic with otorhinolaryngological, pneumological, cardiac, digestive, neurological, muscular attacks with a higher mortality in subjects with comorbidity [> 70 years old, cardiovascular history in particular Arterial hypertension (hypertension ), heart disease…]. This polymorphism is linked to vasculitis and the immune response. Patients with cardiovascular disease are particularly at risk of decompensating, particularly due to the increased metabolism induced by viral infection and reduced cardiovascular capacities. On the cardiovascular level, two sides can be considered. On the one hand, cardiovascular disease (hypertension, coronary artery disease) is a comorbid factor. On the other hand, the myocardial damage reflected by the increase in troponin or an alteration of the ejection fraction is a very clear risk factor for death or severe form. Cardiovascular involvement is particularly high in hospitalized and deceased patients. The odds ratio calculated in a meta-analysis of severe forms of covid-19 with hypertension is 3 [1.9; 3.1], for cardiovascular pathologies of 2.93 [1.73; 4.96]. Recommendations were made for pulmonary rehabilitation but not for cardiovascular rehabilitation. Cardiac rehabilitation is indicated in most cardiovascular pathologies (after acute coronary syndrome, after coronary angioplasty, in heart failure, after coronary or valve heart surgery, etc.). It consists of a multidisciplinary approach combining therapeutic pharmacological adjustment, physical activity, therapeutic education in order to improve physical capacities for exertion and reduce morbidity and mortality. The physical exercises can be endurance or resistance type. Capacity gain at the end of rehabilitation is measured by visual scales, quality of life questionnaires, and a stress test at the start and end of rehabilitation. Most often, rehabilitation centers only do the stress test and estimate through questioning for subjective improvement. The hypothesis is that patients who contracted COVID-19 would have lower cardiac capacities after recovery from the infection than patients without COVID-19 or that their capacity for recovery would be less. There could be a difference in recovery after cardiac rehabilitation between the two populations regardless of whether the cardiac damage requiring rehabilitation was triggered by COVID-19 or was pre-existing.
Description: This outcome corresponds to the difference between the average gain in exercise capacity after cardiac rehabilitation between the two groups of patients Control and COVID-19.
Measure: Impact of COVID-19 on exercise capacity gain after cardiovascular rehabilitation Time: Month 3Patients are part of a family network. When any person in a family becomes critically unwell and requires the assistance of an Intensive Care Unit (ICU), this has an impact on all members of that family. COVID-19 changed visiting for all patients in hospitals across Scotland. It is not known what effect these restrictions will have on patients' recovery, nor do we understand the impact it may have on their relatives or staff caring for them. This study will look at the implications of the visiting restrictions as a consequence of the COVID-19 pandemic upon patients without COVID-19 who are in the cardiothoracic ICU. It will also explore the impact of these restrictions on them, their relatives and staff. This study will be carried out within a single specialised intensive care unit in Scotland using mixed methods. The first arm of this study will use retrospective data that is routinely collected in normal clinical practice. The investigators will compare patient outcomes prior to COVID-19 with outcomes following the implementation of COVID-19 visiting restrictions. The aim is to establish if the restrictions on visiting has an impact on the duration of delirium. Delirium is an acute mental confusion and is associated with longer hospital stays and worse outcomes in this patient group. The second arm of this study involves semi-structured interviews with patients, relatives and staff that will allow deeper exploration of the issues around current visiting policy. The interviews will last approximately 1 hour and will address these issues. They will then be transcribed word for word and analysed using grounded theory, meaning the theories will develop from the data as it is analysed.
Description: Number of days patient found to have delirium using the Confusion Assessment Method for the ICU (CAM-ICU)
Measure: Duration of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.Description: CAM-ICU
Measure: Incidence of delirium Time: From the date of admission to the Intensive Care Unit (ICU) until discharge from the ICU or death, whichever came first, up to 12 months.Description: Days
Measure: Length of critical care stay Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.Description: Days
Measure: Length of hospital stay Time: From the date of admission to the hospital until discharge from the hospital or death, whichever came first, up to 12 months.Description: Days
Measure: Length of time ventilated Time: From the date of admission to the ICU until discharge from the ICU or death, whichever came first, up to 12 months.Description: Semi structured interviews
Measure: Exploring the experiences of patients, relatives and staff of the visitation restrictions during the COVID-19 pandemic Time: 18 monthsThe purpose of the study is to evaluate the efficacy and safety of AZD9977 alone and AZD9977 in combination with dapagliflozin and to assess the dose-response relationship of placebo, AZD9977 alone, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 55%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between 20 and 60 mL/min, with at least 30% of participants with eGFR <30 mL/min and a maximum of 25% of participants with eGFR >45 mL/min]), including at least 40% of participants with type 2 diabetes mellitus (T2DM).
Description: Evaluating the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on UACR.
Measure: Percent change from baseline in UACR at 12 weeks Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the dose-response relationship of placebo, AZD9977 (Dose C) alone, dapagliflozin (10 mg) alone and 3 doses of AZD9977 (A, B or C) combined with dapagliflozin (10 mg) on UACR.
Measure: Percent change from baseline in UACR at 12 weeks to assess dose-response relationship Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the general safety and tolerability of AZD9977 and dapagliflozin in combination and alone compared with placebo.
Measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From baseline (Day 1) until Day 113 (Safety Follow-up)Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Absolute value of serum potassium over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Change from baseline in serum potassium over time Time: From baseline (Day 1), Day 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Absolute value of eGFR over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Change from baseline in eGFR over time Time: From baseline (Day 1), Day 3 until Day 85Abbreviations/acronyms: DUO-EF = prediction of ejection fraction (EF) using the Eko-DUO digital stethoscope algorithm HF = heart failure HFrEF = heart failure with reduced ejection fraction COVID-19 = coronavirus disease 2019 Eko DUO = digital stethoscope device cMRI = cardiac magnetic resonance imaging ECG = electrocardiogram Prospective observational study of left ventricular ejection fraction predicted by application of artificial intelligence to single-lead ECG acquired by a digital stethoscope; in the post-covid-19 follow up clinic, in patients presenting with heart failure symptoms in primary care, and in patients attending for echocardiography and cardiac MRI.
Description: Area under curve (AUC) where maximum value is '1', describing ability of algorithm to discriminate low from not-low ejection fraction
Measure: Area under receiver operating curve Time: up to 18 monthsAlthough COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.
Description: Hypokinetic left ventricle function (left ventricle ejection fraction <45%)
Measure: Percentage of patients with left ventricle dysfunction (hypokinetic) Time: 3 monthDescription: Acute cor pulmonale was defined as a dilated right ventricle (right ventricle end-diastolic area/left ventricle end-diastolic area ratio >0.6) associated with the presence of paradoxical septum motion
Measure: Percentage of patients with acute cor pulmonale Time: 3 monthDescription: Respiratory system compliance is defined as the change in lung volume (Tidal volume, ml) produced by a unit change in pulmonary pressure (driving pressure, cmH2O). The reported value of respiratory system compliance will be reported in ml/cmH2O.
Measure: Differences in respiratory system compliance between patients with and without acute cor pulmonale Time: Within the first 24 hours of mechanical ventilation.Description: Partial arterial pressure of carbon dioxide will be reported in mmHg.
Measure: Differences in partial arterial pressure of carbon dioxide (PCO2) between patients with and without acute cor pulmonale Time: Within the first 24 hours of mechanical ventilation.Description: PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction). The reported value is a positive integer.
Measure: Differences in PaO2/FiO2 ratio between patients with and without acute cor pulmonale Time: Within the first 24 hours of mechanical ventilation.This first-time-in-human (FTIH) study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single doses of AZD3427 in healthy volunteers and multiple doses of AZD3427 in patients with heart failure (HF).
Description: Assessment of the safety and tolerability of single and multiple ascending doses of AZD3427.
Measure: Number of Participants Experiencing Adverse Events and Serious Adverse Events Time: Part A: Day 1 until Day 50 or Early termination visit (E/T); Part B: Day 1 until Day 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Maximum Observed Serum (peak) Drug Concentration (Cmax) of AZD3427 Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under the Serum Concentration-time Curve from Zero to the Last Quantifiable Concentration (AUClast) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under Serum Concentration-time Curve From Zero to Infinity (AUCinf) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under the Serum Concentration-time Curve from Zero to 168 Hours Post-dose Administration (AUC0-168) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (tmax) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Number of Participants Testing Positive for the Presence of Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to AZD3427 Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Evaluation of Positive Anti-drug Antibodies Titer Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Evaluation of Neutralizing Antibodies Titer Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/THeart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Many studies reported that depression is prevalent among HF patients and it is being associated with high morbidity, mortality and costs. The European Society of Cardiology guidelines stresses the importance of routine depression screening with a validated questionnaire and initiating treatment for depression for all depressed HF patients and their access to psychological treatment. The community heart failure nurses provide the integrated heart failure service in the local area of Southwark and Lambeth in South London. The aim of the integrated heart failure team in the community is to provide the HF treatment effectively, help patients understand and manage their symptoms and support with lifestyle changes. Even though, the community HF nurses have extensive role in managing HF patients in the community, their role in assessing anxiety and depression; and providing psychological treatment needs to be further explored. Therefore, there is a need to assess the process by which community HF nurses assess and manage anxiety and depression. This current study builds on our recent systematic review which illustrated how cognitive behaviour therapy is effective at improving depressive symptoms in HF, but more studies are needed to build on these findings. The findings from this review will be used to examine the perspectives on assessing, managing and treating depression and anxiety in HF patients. In this current study, an online focus group with community heart failure nurses and qualitative telephone/online interviews with community-based HF patients will be undertaken to explore their views and experiences in managing depression and anxiety; and to assess whether COMPASS a web-based intervention would be useful. Also, this study will explore the impact of COVID-19 on the psychological wellbeing of community-based HF patients.
Description: will explore nurses' perception regarding the assessment and management of depression and anxiety in heart failure by undertaking an online focus group with community heart failure nurses.
Measure: Explore community heart failure nurses' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions. Time: This will take place before the introduction of COMPASS web-based intervention.Description: will explore patients' perception regarding the assessment and management of depression and anxiety in heart failure. This will be done by undertaking online\telephone interviews with community-based heart failure patients.
Measure: Explore community heart failure patients' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions. Time: This will take place before the introduction of COMPASS web-based intervention.Description: will explore nurses' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure in an online focus group.
Measure: Explore nurses' perception of using web-based COMPASS intervention for depression and anxiety management in HF Time: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.Description: will explore patients' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure. This will be done by conducting online\telephone interviews with community-based heart failure patients.
Measure: Explore patients' perception of using web-based COMPASS intervention for depression and anxiety management in HF Time: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.Description: will discuss with community HF nurses the impact of COVID-19 on the psychological wellbeing of community-based HF patients and how it changed their access to psychological intervention. This will form part of the online focus group.
Measure: Explore with community HF nurses the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes. Time: This will take place before the introduction of COMPASS web-based intervention.Description: will explore with community HF patients the impact of COVID-19 on the psychological wellbeing of community-based HF patients and how it changed their access to psychological intervention. This will form part of the online/telephone interviews.
Measure: Explore with community HF patients the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes. Time: This will take place before the introduction of COMPASS web-based intervention.Sufficient muscle strength helps to get out of a chair and can prevent falls. Up to 30% of older adults experience age-related loss of muscle strength, which can lead to frailty and health instability. Exercise helps to build muscle, maintain bone density and prevent chronic disease, especially during the aging process. In older adults at risk of mobility impairment, exercise greatly reduced incidence and effects did not vary by frailty status. However, more than 75% of Canadian adults ≥18 years of age are not meeting physical activity guidelines. In addition, it is known know that malnutrition, including low protein intake, may lead to poor physical function. While there are services to support exercise and nutrition, barriers to implementing them persist. The COVID-19 pandemic has exacerbated the potential for physical inactivity, malnutrition, and loneliness among older adults, especially those with pre-existing health or mobility impairments. Now and in future, alternate ways to promote exercise and proper nutrition to the most vulnerable are needed. The investigators propose to adapt MoveStrong, an 8-week education program combining functional strength and balance training with strategies to increase protein intake. The program was co-developed with patient advocates, Osteoporosis Canada, the YMCA, Community Support Connections and others. MoveStrong will be delivered by telephone or web conference to older adults in their homes, using mailed program instructions, 1-on-1 training sessions through Physitrack®, as well as online nutrition seminars and support groups over Microsoft® Teams. The primary aim of this study is to assess feasibility as determined by recruitment (25 people in 3 months), retention (80%), adherence (≥70%) and participant experience.
Description: The number of participants recruited at the end of rollout and participant experience.
Measure: Recruitment Time: Through study completion, an average of 12 weeksDescription: The number of participants retained at post-rollout end
Measure: Retention Time: Through study completion, an average of 12 weeksDescription: The percentage of exercise sessions completed
Measure: Adherence Time: Through study completion, an average of 12 weeksDescription: A semi-structured interview will ask about participant experience, satisfaction, learning needs, and suggested adaptations to the program. A semi-structured interview guide has been designed to conduct exit interviews and follow up interviews with each participant over the phone or web conference. Interviews will be audio-recorded and transcribed verbatim. One researcher will perform content analyses using NVivo version 12 Pro or higher (QSR International Pty Ltd, 2019) to describe participant experience, satisfaction, learning needs and suggested adaptations to the program. Analyses will be verified by another researcher through member checking. The exercise physiologist will be given a spreadsheet to record any protocol adaptations, challenges, and successes to inform future trials.
Measure: Participant experience Time: Week 12Description: A Physical Activity Screen (PAS) will be used to capture average minutes of moderate-to-vigorous physical activity each week. This tool was created based on questions used by Exercise is Medicine in the Physical Activity Vital Sign questionnaire (Greenwood et al., 2010). The results will be compared to national exercise guidelines for older adults that promote ≥150 minutes and ≥2 session of muscle strengthening per week (Tremblay et al., 2011).
Measure: Physical activity Time: Baseline, week 9, week 12Description: A modified version of the Exercise Self-Efficacy Scale will be used to capture levels of planning and execution of exercise related activities (Resnick & Jenkins, 2000). The lowest response option to each question is "Not true at all", while the highest is "Exactly true". Responses closer to "Exactly true" indicate a better outcome.
Measure: Exercise self-efficacy scale Time: Baseline, week 9, week 12Description: The 30-second Chair Stand will be used to access lower extremity muscle function (Bohannon, 1995; Jones et al., 1999). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.
Measure: 30-second Chair Stand Time: Baseline, week 9, week 12Description: Static balance will be measured using the 3-point scale from the Short Performance Physical Battery (J. M. Guralnik et al., 1994). The instructions for this test have been adapted and will be self-administered under the remote supervisor supervision of the exercise physiologist. A higher score on this test indicates a better outcome.
Measure: Static balance Time: Baseline, week 9, week 12Description: Fatigue will be assessed with the Center for Epidemiologic Studies Depression Scale-fatigue questions (CES-D) Depression Scale (Radloff, 1977). Only two questions on the CES-D will be used: "I felt that everything I did was an effort, "I could not get going". The lowest response option is "Rarely (<1 day)", and the highest response option is "Nearly every day". Responses closer to the lowest response option indicate a better outcome.
Measure: Fatigue Time: Baseline, week 9, week 12Description: Warwick-Edinburgh Mental Well-being Scale focuses on positive aspects of mental health. It is short, yet robust and showed high correlations with other mental health and well-being scales. The lowest response option is "None of the time", and the highest response option is "All of the time". Responses closer to the highest response option indicate a better outcome.
Measure: Mental health and social isolation Time: Baseline, week 9, week 12Description: The EuroQol Group 5 Dimension 5 Level questionnaire is a multi-attribute health related quality of life tool (Herdman et al., 2011). The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems to extreme problems five dimensions can be combined into a 5-digit number that describes the self rated patient's health state. Responses to each dimension are scored as a number from 1-5. Responses scored as 1 indicate a better outcome.
Measure: Quality of life score Time: Baseline, week 9, week 12Description: The SCREEN tool is a valid and reliable nutrition questionnaire designed specifically for older adults (Keller et al., 2005). This tool will be used to assess changes in weight, appetite, eating habits and promote viable self-management.
Measure: Dietary intake Time: Baseline, week 9, week 12Description: ASA24®-Canada is a guided web-based tool used for 24-hour diet recalls. All food and drinks consumed by the participant on two weekdays and one weekend day (3 days in total) will be reported to track protein intake (Subar et al., 2012).
Measure: Nutrition tracking Time: Baseline, week 9, week 12Description: We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Measure: Number of adverse events Time: Through study completion, an average of 12 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports