Arrhythmia, Atrial Fibrillation, Heart Disease
Conditions
Keywords
atrial fibrillation, angiotensin II, angiotensin receptor antagonist, drug, controlled clinical trial
Brief summary
Hypothesis: Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25% compared to standard medication without angiotensin II type 1 receptor. A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic recovery medication (amiodarone) is allowed during follow-up.
Detailed description
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
Interventions
DRUGOlmesartan
Sponsors
Daiichi Sankyo
Atrial Fibrillation Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation. * Age ≥ 18 * Patient informed orally and in writing * Written informed consent of the patient
Exclusion criteria
* Strong clinical evidence for therapy with AT II/ACE inhibitors * AT II/ACE inhibitor therapy within the last month * Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months * Direct current (DC) cardioversion within the last 3 months * Symptomatic bradycardia * Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use * Cardiac surgery or cardiac catheter ablation within the last 3 months * Typical angina pectoris symptoms at rest or during exercise * Known coronary artery disease with indication for intervention * Valvular disease \> II degree * Left ventricular ejection fraction \< 40% * Diastolic blood pressure \> 110mm Hg at rest * Symptomatic arterial hypotension * Known renal artery stenosis * Serum creatinine \> 1.8 mval/l * Relevant hepatic or pulmonary disorders * Hyperthyroidism manifested clinically and in laboratory * Known drug intolerance for AT II inhibitors * Females who are pregnant or breast feeding * Females of childbearing potential who are not using a scientifically accepted method of contraception * Participation in a clinical trial within the last 30 days * Drug addiction or chronic alcohol abuse * Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study * Evidence of an uncooperative attitude
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording) | 12 months follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of a symptomatic documented episode of AF | 12 months follow up |
| Time to persistent atrial fibrillation | 12 months follow up |
| Time to prescription of the recovery-medication | 12 months follow up |
| Time to first occurrence of a documented relapse of atrial fibrillation | 12 months follow up |
| Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization | 12 months follow up |
| Number of cerebrovascular events | 12 months follow up |
| Quality of life | 12 months follow up |
| Number of hospitalizations for cardiovascular reasons (-> Endpoint review) | 12 months follow up |
Outcome results
None listed