Covid 19 Clinical Trials

HP:0001635: Congestive heart failureHPO

Developed by Shray Alag

Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (19)

	Name (Synonyms)	Correlation
drug974	Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors Wiki	0.33
drug2842	Tele-medicine platform Wiki	0.33
drug2018	PB1046 Wiki	0.33
drug30	2: No instruction regarding positioning Wiki	0.33
drug869	Device used to record voice for screening Wiki	0.33
drug1682	Maraviroc+Favipiravir+CT Wiki	0.33
drug1609	Low Dose (10 mg) Control Wiki	0.33
drug1143	Furosemide Injection, USP Wiki	0.33
drug1142	Furosemide Injection Solution for subcutaneous administration (80 mg) Wiki	0.33
drug21	1: Prone positioning Wiki	0.33
drug2569	Satisfaction evaluation Wiki	0.33
drug2088	Performance of WHEELS-I in promoting DASH/SRD adoption Wiki	0.33
drug949	EHR-based Clinician Jumpstart Wiki	0.33
drug15	14C-lazertinib Wiki	0.33
drug802	Curently used therapy for COVID-19 non-critical patients Wiki	0.33
drug1092	Favipiravir + Currently used therapy Wiki	0.33
drug1680	Maraviroc + Currently used therapy Wiki	0.33
drug313	Azithromycin Wiki	0.06
drug1284	Hydroxychloroquine Wiki	0.03

Correlated MeSH Terms (46)

	Name (Synonyms)	Correlation
D006333	Heart Failure NIH	1.00
D054143	Heart Failure, Systolic NIH	0.47
D002561	Cerebrovascular Disorders NIH	0.33
D000787	Angina Pectoris NIH	0.33
D019462	Syncope, Vasovagal NIH	0.33
D013575	Syncope NIH	0.33
D054144	Heart Failure, Diastolic NIH	0.33
D013616	Tachycardia, Sinus NIH	0.33
D007022	Hypotension NIH	0.33
D054058	Acute Coronary Syndrome NIH	0.30
D003327	Coronary Disease NIH	0.27
D015673	Fatigue Syndrome, Chronic NIH	0.24
D000075902	Clinical Deterioration NIH	0.24
D002546	Ischemic Attack, Transient NIH	0.24
D001281	Atrial Fibrillation NIH	0.24
D024821	Metabolic Syndrome NIH	0.24
D016491	Peripheral Vascular Diseases NIH	0.24
D011654	Pulmonary Edema NIH	0.24
D013610	Tachycardia NIH	0.24
D058729	Peripheral Arterial Disease NIH	0.19
D005356	Fibromyalgia NIH	0.19
D014652	Vascular Diseases NIH	0.19
D009203	Myocardial Ischemia NIH	0.19
D016584	Panic Disorder NIH	0.19
D009362	Neoplasm Metastasis NIH	0.17
D003324	Coronary Artery Disease NIH	0.17
D008103	Liver Cirrhosis, NIH	0.17
D051437	Renal Insufficiency, NIH	0.15
D008175	Lung Neoplasms NIH	0.15
D002318	Cardiovascular Diseases NIH	0.13
D011665	Pulmonary Valve Insufficiency NIH	0.13
D007676	Kidney Failure, Chronic NIH	0.13
D029424	Pulmonary Disease, Chronic Obstructive NIH	0.12
D006331	Heart Diseases NIH	0.12
D013577	Syndrome NIH	0.10
D017563	Lung Diseases, Interstitial NIH	0.10
D002908	Chronic Disease NIH	0.10
D008171	Lung Diseases, NIH	0.08
D009369	Neoplasms, NIH	0.07
D007249	Inflammation NIH	0.06
D055371	Acute Lung Injury NIH	0.03
D012127	Respiratory Distress Syndrome, Newborn NIH	0.03
D012128	Respiratory Distress Syndrome, Adult NIH	0.03
D011014	Pneumonia NIH	0.02
D045169	Severe Acute Respiratory Syndrome NIH	0.02
D018352	Coronavirus Infections NIH	0.01

Correlated HPO Terms (22)

	Name (Synonyms)	Correlation
HP:0011703	Sinus tachycardia HPO	0.33
HP:0002615	Hypotension HPO	0.33
HP:0012668	Vasovagal syncope HPO	0.33
HP:0001681	Angina pectoris HPO	0.33
HP:0001279	Syncope HPO	0.33
HP:0001649	Tachycardia HPO	0.24
HP:0004757	Paroxysmal atrial fibrillation HPO	0.24
HP:0002326	Transient ischemic attack HPO	0.24
HP:0100598	Pulmonary edema HPO	0.24
HP:0001658	Myocardial infarction HPO	0.19
HP:0001677	Coronary artery atherosclerosis HPO	0.17
HP:0001395	Hepatic fibrosis HPO	0.17
HP:0004950	Peripheral arterial stenosis HPO	0.15
HP:0000083	Renal insufficiency HPO	0.15
HP:0100526	Neoplasm of the lung HPO	0.15
HP:0010444	Pulmonary insufficiency HPO	0.13
HP:0001626	Abnormality of the cardiovascular system HPO	0.12
HP:0006510	Chronic pulmonary obstruction HPO	0.12
HP:0006515	Interstitial pneumonitis HPO	0.10
HP:0002088	Abnormal lung morphology HPO	0.08
HP:0002664	Neoplasm HPO	0.07
HP:0002090	Pneumonia HPO	0.02

There are 9 clinical trials

Clinical Trials

1 Essential Arterial Hypotension and Allostasis Registry

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.

NCT02018497 Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope

MeSH:Fatigue Syndrome, Chronic Fibromyalgia Syncope Ischemic Attack, Transient Cerebrovascular Disorders Syncope, Vasovagal Heart Failure Atrial Fibrillation Heart Diseases Myocardial Infarction Acute Coronary Syndrome Hypotension Coron Coronary Disease Tachycardia Heart Failure, Diastolic Heart Failure, Systolic Tachycardia, Sinus Syndrome Panic Disorder

HPO:Atrial fibrillation Carotid sinus syncope Congestive heart failure Hypotension Left ventricular dysfunction Myocardial infarction Paroxysmal atrial fibrillation Right ventricular failure Sinus tachycardia Syncope Tachycardia Transient ischemic attack Vasovagal syncope

Primary Outcomes

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 study

Description: 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 study

Description: 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 study

Secondary Outcomes

Description: 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 study

Description: 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 study

Description: 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 study

Description: 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 study

Other Outcomes

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Measure: Neurally Mediated Syncope: further of the transient lost of consciousness (TLC)

Time: A 7-year prospective study

Description: 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 weeks

Description: 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 years

Description: 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 year

Description: 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 years

Description: 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 years

2 Dietary Prevention of Heart Failure in Hypertensive Metabolic Syndrome

Tens 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.

NCT03170375 Heart Failure Behavioral: Performance of WHEELS-I in promoting DASH/SRD adoption Behavioral: Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors

MeSH:Heart Failure Metabolic Syndrome

HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

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 4

Description: Left ventricular mass indexed to height

Measure: Left ventricular mass index

Time: Phase 2 of study, change from baseline to 6 months

Secondary Outcomes

Description: 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 4

Description: 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 4

Description: 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 4

Description: 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 months

Description: Left atrial volume by 3D echocardiography

Measure: Left atrial volume

Time: Phase 2 of study, change from baseline to 6 months

Other Outcomes

Description: 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 4

Description: Measure of dietary sodium intake

Measure: 24-hour urinary sodium excretion

Time: Phase 2 of study, change from baseline to 6 months

Description: 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 months

Description: 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 6

3 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

The 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.

NCT04281784 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failure，Congestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart

MeSH:Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease Neoplasms

HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

Primary Outcomes

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 randomization

Secondary Outcomes

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: 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 randomization

Description: From Washington State death certificates.

Measure: All-cause mortality at 1 year (safety outcome)

Time: 1 year after randomization

Other Outcomes

Description: 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 randomization

4 Integrated Distance Management Strategy for Patients With Cardiovascular Disease (Ischaemic Coronary Artery Disease, High Blood Pressure, Heart Failure) in the Context of the COVID-19 Pandemic

Management 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.

NCT04325867 Angina Pectoris Acute Coronary Syndrome Coronary Syndrome Coronary Artery Disease Angioplasty Stent Restenosis Hypertension Heart Failure, Systolic Depression, Anxiety Covid-19 Isolation, Social Other: Tele-medicine platform

MeSH:Heart Failure Coronary Artery Disease Myocardial Ischemia Coronary Disease Acute Coronary Syndrome Angina Pectoris Heart Failure, Systolic Syndrome Cardiovascular Diseases

HPO:Abnormality of the cardiovascular system Angina pectoris Congestive heart failure Coronary artery atherosclerosis Left ventricular dysfunction Myocardial infarction Right ventricular failure

Primary Outcomes

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 months

Description: 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 months

Secondary Outcomes

Description: Will be the number of sessions per patient multiplied with the number of patients included

Measure: Number of consultations/sessions given

Time: 6 months

5 An Open-label, Single-dose, Randomized, Two-way, Two-period Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80 mg) Administered Intravenously in Subjects With Chronic Heart Failure

The 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.

NCT04384653 Heart Failure Drug: Furosemide Injection Solution for subcutaneous administration (80 mg) Drug: Furosemide Injection, USP

MeSH:Heart Failure

HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

Description: Maximum plasma furosemide concentration after administration by subcutaneous infusion or IV bolus

Measure: Pharmacokinetic - Cmax

Time: 0 to 24 hours

Description: 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 hours

Description: AUC from time 0 to infinity for plasma furosemide after administration by subcutaneous infusion or IV bolus

Measure: Pharmacokinetic - AUCinf

Time: 0 to 24 hours

Secondary Outcomes

Description: Total collected urine volume after furosemide administration by subcutaneous infusion or IV bolus

Measure: Pharmacodynamic - Diuresis

Time: 0 to 8 hours

Description: Total collected urine volume after furosemide administration by subcutaneous infusion or IV bolus

Measure: Pharmacodynamic - Diuresis

Time: 0 to 24 hours

Description: Total sodium concentration in urine after furosemide administration by subcutaneous infusion or IV bolus

Measure: Pharmacodynamic - Natriuresis

Time: 0 to 8 hours

Description: Total sodium concentration in urine after furosemide administration by subcutaneous infusion or IV bolus

Measure: Pharmacodynamic - Natriuresis

Time: 0 to 24 hours

6 COVID-19 in Hospitalised Patients With Preexisting CArdioVascular Diseases and/or Cardiac Involvement and/or Cardiovascular Risk Factors: the Global PCHF-COVICAV Registry

Background: 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.

NCT04390555 COVID-19 Cardiovascular Diseases Cardiovascular Risk Factor Heart Failure

MeSH:Heart Failure Cardiovascular Diseases

HPO:Abnormality of the cardiovascular system Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

Description: All-cause and cardiovascular mortality during index hospitalization.

Measure: In-hospital mortality.

Time: Hospitalization period, assessed up to 30 days

Secondary Outcomes

Description: 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 days

Description: The total length of stay in the hospital.

Measure: The duration of hospitalization.

Time: Hospitalization period, assessed up to 30 days

Measure: The need and duration of invasive mechanical ventilation.

Time: Hospitalization period, assessed up to 30 days

Measure: Hospitalization for cardiovascular causes or cardiovascular deaths within 3 months after hospitalization.

Time: 3 months

Measure: Hospitalization for cardiovascular causes or cardiovascular deaths within 6 months after hospitalization.

Time: 6 months

7 Extracorporeal Membrane Oxygenation (ECMO) as a Therapeutic Option in Severe Form of COVID-19: a Nationwide Cohort Study

The 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.

NCT04397588 ARDS Related to Severe Acute Respiratory Syndrome-Coronavirus (SARS-CoV) 2 Acute Refractory Heart Failure Related to SARS-CoV 2

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Heart Failure

HPO:Congestive heart failure Left ventricular dysfunction Right ventricular failure

Primary Outcomes

Description: Hospital mortality

Measure: Hospital mortality

Time: up to 90 days

Secondary Outcomes

Description: Mortality Day 28

Measure: Mortality Day 28

Time: Day 28

Description: Mortality Day 90

Measure: Mortality Day 90

Time: Day 90

Description: Ventilator-free days

Measure: Ventilator-free days

Time: Day 28

Description: ICU-free days

Measure: Intensive care unit-free days

Time: Day 28

Description: Hospital-free days

Measure: Hospital-free days

Time: Day 28

8 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of PB1046, a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)

This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure 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.

NCT04433546 Acute Respiratory Distress Syndrome Coronavirus Hypoxic Respiratory Failure Hypoxemic Respiratory Failure Respiratory Complication Respiratory Insufficiency Cardiac Dysfunction Pneumonia Pulmonary Edema Pulmonary Inflammation Respiratory Failure Cytokine Storm COVID 19 SARS-CoV-2 Cardiac Event Cardiac Complication Cardiac Failure Cardiac Infarct Drug: PB1046 Drug: Low Dose (10 mg) Control

MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Edema Pulmonary Valve Insufficiency Heart Failure Syndrome Inflammation Clinical Deterioration

HPO:Congestive heart failure Left ventricular dysfunction Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure

Primary Outcomes

Measure: Days alive and free of respiratory failure from initiation of PB1046

Time: 28 days

Secondary Outcomes

Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge)

Time: 28 days

Description: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen

Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization

Time: Any time point between injection initiation and Day 28

Measure: All-cause mortality

Time: 28 days

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 days

Measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first.

Time: Any time point between injection initiation and Day 28

Measure: Change from baseline in cardiac marker high sensitivity troponin I (hsTnI)