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    HP:0004757: Paroxysmal atrial fibrillation

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (12)


    Name (Synonyms) Correlation
    drug4231 Symptoms questionnare Wiki 0.50
    drug1540 Esophageal temperature monitoring probe Wiki 0.50
    drug810 COVID-19 PCR and serology testing Wiki 0.50
    Name (Synonyms) Correlation
    drug3068 PT-X and IMT Wiki 0.50
    drug5115 oropharyngeal swabs Wiki 0.50
    drug4936 ensoETM. Esophageal cooling during AF ablation Wiki 0.50
    drug814 COVID-19 Serology Wiki 0.35
    drug689 Breath Biopsy face masks with removable filters and fitted PVA strip Wiki 0.35
    drug72 50 mg/mL Virazole Wiki 0.35
    drug26 100 mg/mL Virazole Wiki 0.35
    drug813 COVID-19 RT-PCR Wiki 0.29
    drug2761 Nasopharyngeal swab Wiki 0.18

    Correlated MeSH Terms (25)


    Name (Synonyms) Correlation
    D001281 Atrial Fibrillation NIH 1.00
    D016171 Torsades de Pointes NIH 0.50
    D001919 Bradycardia NIH 0.50
    Name (Synonyms) Correlation
    D054537 Atrioventricular Block NIH 0.50
    D004937 Esophageal Fistula NIH 0.50
    D002561 Cerebrovascular Disorders NIH 0.50
    D019462 Syncope, Vasovagal NIH 0.50
    D013575 Syncope NIH 0.50
    D054144 Heart Failure, Diastolic NIH 0.50
    D013616 Tachycardia, Sinus NIH 0.50
    D007022 Hypotension NIH 0.35
    D002546 Ischemic Attack, Transient NIH 0.35
    D054143 Heart Failure, Systolic NIH 0.35
    D005402 Fistula NIH 0.29
    D015673 Fatigue Syndrome, Chronic NIH 0.29
    D013610 Tachycardia NIH 0.29
    D016584 Panic Disorder NIH 0.25
    D001145 Arrhythmias, Cardiac NIH 0.25
    D005356 Fibromyalgia NIH 0.22
    D054058 Acute Coronary Syndrome NIH 0.20
    D003327 Coronary Disease NIH 0.19
    D006331 Heart Diseases NIH 0.13
    D006333 Heart Failure NIH 0.13
    D009203 Myocardial Ischemia NIH 0.11
    D013577 Syndrome NIH 0.04

    Correlated HPO Terms (12)


    Name (Synonyms) Correlation
    HP:0012668 Vasovagal syncope HPO 0.50
    HP:0001664 Torsade de pointes HPO 0.50
    HP:0001662 Bradycardia HPO 0.50
    Name (Synonyms) Correlation
    HP:0011703 Sinus tachycardia HPO 0.50
    HP:0001678 Atrioventricular block HPO 0.50
    HP:0001279 Syncope HPO 0.50
    HP:0002615 Hypotension HPO 0.35
    HP:0002326 Transient ischemic attack HPO 0.35
    HP:0001649 Tachycardia HPO 0.29
    HP:0011675 Arrhythmia HPO 0.25
    HP:0001635 Congestive heart failure HPO 0.13
    HP:0001658 Myocardial infarction HPO 0.11

    Clinical Trials

    Navigate: Correlations   HPO

    There are 4 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
    Conditions
    1. Blood Pressure
    2. Depression
    3. Panic Attack
    4. Fibromyalgia
    5. POTS
    6. Inappropriate Sinus Tachycardia
    7. Coronary Heart Disease
    8. Acute Coronary Syndrome (ACS)
    9. Acute Myocardial Infarction (AMI)
    10. Cerebrovascular Disease (CVD)
    11. Transient Ischemic Attack (TIA)
    12. Atrial Fibrillation
    13. Diabetes Mellitus
    14. Cancer
    15. Systolic Heart Failure
    16. Diastolic Heart Failure
    17. Chronic Fatigue Syndrome
    18. Syncope
    19. Vasovagal Syncope
    MeSH:Fatigue Syndrome, Chronic Fibromyalgia Syncope Ischemic Attack, Transient Cerebrovascular Disorders Syncope, Vasovagal Heart Failure Atrial Fibrillation Myocardial Infarction Heart Diseases Acute Coronary Syndrome Hypotension Coronary Disease Tachycardia Heart Failure, Diastolic Heart Failure, Systolic Tachycardia, Sinus Syndrome Panic Disorder
    HPO:Abnormal left ventricular function Atrial fibrillation Carotid sinus syncope Congestive heart failure Hypotension 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

    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, COPD, and others. Mortality

    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 COVIDAR - International Registry on Arrhythmias in COVID-19

    BACKGROUND AND RATIONALE: There is very limited literature available on the arrhythmia occurrence in the context of an infection by the SARS-CoV2 virus. On the other hand, treatment strategies against the SARS-CoV2 virus may carry a risk of QTc prolongation and pro-arrhythmia/sudden death which may be amplified by concomitant use of other QTc-prolonging drugs and/or ion disbalances. COVIDAR is an international initiative to monitor the occurrence of arrhythmic events in the context of the SARS-CoV2 infection, to identify potential modifiable predisposing factors to reduce their incidence and to inform the best arrhythmia management options in this patient population. MAIN OBJECTIVE: To describe the incidence and type of arrhythmic events in the context of the SARS-CoV2 infection. STUDY DESIGN: patient registry (observational). Patients will not undergo any additional investigations. Only data that is generated during routine clinical care will be collected. STUDY POPULATION: Patients admitted to the hospital highly suspected of or with confirmed COVID-19.

    NCT04437901
    Conditions
    1. COVID
    2. Arrhythmia
    3. Torsades de Pointe Caused by Drug
    4. Qt Interval, Variation in
    5. Atrioventricular Block
    6. Atrial Fibrillation
    7. Bradyarrhythmia
    8. Ventricular Arrythmia
    MeSH:Atrial Fibrillation Arrhythmias, Cardiac Atrioventricular Block Bradycardia Torsades de Pointes
    HPO:Arrhythmia Atrial fibrillation Atrioventricular block Bradycardia Paroxysmal atrial fibrillation Torsade de pointes

    Primary Outcomes

    Description: Any arrhythmic event occurring in COVID-19 patients during hospital admission: Monomorphic ventricular tachycardia Polymorphic ventricular tachycardia/Torsades de pointes (non-sustained) Ventricular fibrillation AV-block Severe bradycardia, symptomatic and/or requiring treatment New-onset atrial fibrillation Other

    Measure: Arrhythmia

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Secondary Outcomes

    Description: Categorical variable collecting the patient's underlying rhythm at baseline, on treatment and in case of arrhythmic adverse events): sinus rhythm, atrial fibrillation/flutter, other

    Measure: Electrocardiographic changes - Underlying rhythm

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Collected as a categorical (normal, 1st-, 2nd- or 3rd degree AV block) and a continuous (PR duration in ms) at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Electrocardiographic changes - Atrioventricular conduction

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Electrocardiographic changes - QRS duration

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Collected as a categorical variable (not present, type 1 or type 2) at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Electrocardiographic changes - presence of Brugada QRS pattern

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Collected as a continuous variable (ms) at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Electrocardiographic changes - QTc duration

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Kalium, magnesium and calcium collected as continuous variables at baseline, on treatment and in case of arrhythmic adverse events). Will be reported as a categorical variable (presence/absence) of electrolyte misbalance

    Measure: Laboratory abnormalities - electrolyte misbalance

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Cardiac CK, troponin T and/or troponin I (where available) collected as a continuous variable at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Laboratory abnormalities - cardiac biomarkers

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Creatinine clearance at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Laboratory abnormalities - renal function

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months

    Description: Liver enzymes collected at at baseline, on treatment and in case of arrhythmic adverse events)

    Measure: Laboratory abnormalities - liver function

    Time: From date of admission until the date of first documented arrhythmic adverse event or date of death from any cause, whichever came first, assessed up to 12 months
    3 Improving Oesophageal Protection During AF Ablation: a Multicentre Double-blind Randomized Clinical Trial.

    Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, we have shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before we can say that this type of probe is better in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.

    NCT04577859
    Conditions
    1. AF - Atrial Fibrillation
    2. Complication
    3. Atrio-Esophageal Fistula
    Interventions
    1. Device: ensoETM. Esophageal cooling during AF ablation
    2. Device: Esophageal temperature monitoring probe
    MeSH:Esophageal Fistula Atrial Fibrillation Fistula
    HPO:Atrial fibrillation Paroxysmal atrial fibrillation

    Primary Outcomes

    Description: An upper gastrointestinal endoscopy diagnostic camera is performed under local anaesthetic spray and sedation. This is to screen for ablation-related thermal injury, which is highly characteristic and separate from other pathologies. This is performed for ALL participants of the trial regardless of randomization to study or control group.

    Measure: Incidence and severity of endoscopically detected oesophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours).

    Time: Performed once, at 12-72 hours post ablation

    Secondary Outcomes

    Description: A measure for procedure efficiency

    Measure: Procedure duration (minutes).

    Time: Measured once. At time of AF ablation procedure (day 0)

    Description: A measure for procedure efficiency

    Measure: Fluoroscopy duration (minutes)

    Time: Measured once. At time of AF ablation procedure (day 0)

    Description: A measure of safety of AF ablation across both randomized groups.

    Measure: Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months.

    Time: Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.

    Description: A measure of efficacy and efficiency of the AF ablation procedure: Attainment of ablation targets, including isolation of all veins and production of proven bidirectional block across all lines attempted. Attainment of first-pass isolation for each set of veins Persistence of isolation through waiting period and adenosine test (if used at operator's discretion).

    Measure: Ability to attain procedural endpoints during AF ablation.

    Time: Measured once at time points: time of AF ablation procedure (day 0).

    Description: Incidence of severe gastroenterological symptoms, indicative of oesophageal reflux or gastroparesis, from validated questionnaires (gastro-esophageal reflux disease score (GERDQ) and gastroparesis cardinal symptoms index (GCSI) score) administered >3 months from time of ablation.

    Measure: Incidence of clinically significant chest/gastroenterological symptoms post ablation

    Time: Measured once at time points: 3 months from AF ablation procedure

    Description: Record any evidence of return of the treated arrhythmia at follow up cardiac monitoring: includes, 12 lead ECG, Holter, implantable loop recorders, non-invasive ECG monitors, mobile ECG apps. A return of AF (treated arrhythmia) must satisfy clear ECG/monitoring evidence of AF/related AT for >30 seconds. This is a measure of the success of the AF ablation procedure.

    Measure: Recurrence of treated atrial arrhythmia (AF or related AT)

    Time: Measured at these time points: 3, 6, 12, 24 months from time of ablation procedure.
    4 Physiotherapist Led Exercise Within Cardiac Rehabilitation and Inspiratory Muscle Training and Patients With Paroxysmal Atrial Fibrillation - a Randomized Controlled Trial

    Paroxysmal atrial fibrillation (AF) induce, in the affected patient, a prominent negative effect on health-related quality of life (HR-QoL) and physical fitness. The health care utilisation is high and the patient does never know when the next attack of atrial fibrillation occurs. Therefore, is physical exertion often avoided due to fear of new attacks. Further, are shortness of breath and fatigue often present despite of prescribed modern drugs. Paroxysmal AF per se enhance markedly the risk to develop stroke and heart failure, which both are syndromes that cause further negative effect on the patient´s HR-QoL and physical fitness. Altogether, cause the symptoms in paroxysmal AF a vicious spiral where both VO2max and muscle function deteriorate. The problems with shortness of breath might be due to dysfunction in respiratory muscles. Physiotherapy led exercise within cardiac rehabilitation (PT-X) in combination with inspiratory muscle training (IMT) has shown positive effects in patients with permanent atrial fibrillation. However, to our knowledge, not yet investigated in patients with paroxysmal AF. Aim: Primary to investigate, in a multicentre randomised controlled trial, if PT-X in combination with IMT can impact HR-QoL in patients with paroxysmal AF. Secondary to investigate the effect of PT-X in combination with IMT regarding symptoms, physical fitness, physical activity and the number of atrial fibrillation attacks and health care costs compared to the control group, asked to live their usual life, during the study period. Expected outcome: PTX in combination with IMT can improve HR-QoL, respiratory muscle function, level of symptoms, physical fitness and physical activity in patients with paroxysmal AF. In addition, a reduced number of atrial fibrillation attacks could decrease the direct cost of health care.

    NCT04600713
    Conditions
    1. Atrial Fibrillation Paroxysmal
    Interventions
    1. Other: PT-X and IMT
    MeSH:Atrial Fibrillation
    HPO:Atrial fibrillation Paroxysmal atrial fibrillation

    Primary Outcomes

    Description: The Swedish version of short form 36 (SF-36) will be used for self-reported HR-QoL.

    Measure: Health-related quality of life

    Time: Change from baseline at 12 weeks

    Secondary Outcomes

    Description: Venous blood samples will be obtained according to the European accreditation system.

    Measure: N-terminal pro-B type natriuretic peptide (NT-proBNP)

    Time: At baseline

    Description: Venous blood samples will be obtained investigated with a laboratory method Enzyme- Linked Immunosorbent Assey (ELISA) where antibodies Ig A, Ig G, Ig M will be detected. Due to the fact that the reliability for the laboratory tests to detect antibodies for SARS-CoV-2 is still changing the final decision regarding on which test to use will be made at the start of the study.

    Measure: Antibodies for SARS-CoV-2

    Time: At baseline

    Description: will be measured with MicroRPM (Micro Medical/Care Fusion, Kent, United Kingdom). The respiratory pressure measures inspiratory and expiratory muscle strength.

    Measure: Inspiratory and expiratory muscle strength

    Time: Change from baseline at 12 weeks

    Description: will be measured by a symptom-limited ergometer cycle test based on World Health Organization (WHO) protocol. The workload begins at 25 W or 50 W depending on the anamnesis. The Watts increase every 4.5 min by 25 W until the patient's rates perceived exertion (RPE) 17 (Very Heavy) on the Borg scale. Unless the patient shows any symptoms or signs that demands an earlier stop at the test. Heart rate and blood pressure are assessed at rest and during the test. If the patient do not surpass the last 4.5 minute the watt will be estimated according to Strandells formula.

    Measure: Exercise capacity

    Time: Change from baseline at 12 weeks

    Description: will be measured by a muscle endurance test, including the following: A unilateral isoinertial shoulder flexion test assessed with the patient sitting on a stool with their back touching the wall holding a dumbbell in their hand, 2 kg for women and 3 kg for men. The tested arm is elevated to 90º flexion and the arm not tested is placed in the patient's knee. A pace of 40 beats per min is kept by a digital metronome. Bilateral isometric shoulder abduction is assessed with the patient holding a 1 kg dumbbell in each hand using the same body position as above. The patient is asked to elevate both arms to 90°of shoulder abduction and to maintain this position as long as possible (measured in s). Unilateral isoinertial heel-lift is assessed with the patients performing as many unilateral heel-lifts as possible, with a straight knee, on a 10° tilted wedge, with shoes on. A pace of 60 beats per minutes is kept is kept by a metronome.

    Measure: Muscle function

    Time: Change from baseline at 12 weeks

    Description: will be measured by an accelerometer (Actigraph® GT3x+, Actigraph, Pensacola, Florida, USA). The accelerometer will be worn throughout the whole day during seven days except when taking a bath or a shower. The accelerometer has showed to be valid and reliable in the adult population.

    Measure: Physical activity

    Time: Change from baseline at 12 weeks

    Description: will be measured by short form International Physical Activity Questionnaire (IPAQ). IPAQ measures physical activity during seven days and total time spent sitting a day. IPAQ is validity and reliability tested in several countries.

    Measure: Self reported physical activity

    Time: Change from baseline at 12 weeks

    Description: will be measured by the Hospital Axiently and Depression Scale (HADS ).

    Measure: Self-reported anxiently and depression

    Time: Change from baseline at 12 weeks

    Description: will be measured with a handheld ECG monitor Zenicor-EKG ® (Zenicor Medical Systems AB, Stockholm, Sverige). Zenicor ® has high specificity and sensitivity for detection of sinus rhythm compared to a 24- Holter ECG. Self- reported AF attacks will be logged in a diary.

    Measure: Handheld ECG heart rhythm

    Time: Through the study completion, an avarage of 12 weeks

    Description: are calculated as total costs per patient and the patients medical journal in hospital and primary care.

    Measure: Direct hospital costs related to AF

    Time: Through the study completion, an avarage of 12 weeks

    Other Outcomes

    Description: Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).

    Measure: Ejection fraction

    Time: At baseline

    Description: Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).

    Measure: Left ventricular function

    Time: At baseline

    Description: Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).

    Measure: Diastolic function

    Time: At baseline

    Description: Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).

    Measure: Valvular screening

    Time: At baseline

    HPO Nodes


    Reports

    Data processed on December 13, 2020.

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