Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial
- Conditions
- Paroxysmal Atrial FibrillationCirculatory SystemAtrial fibrillation
- Registration Number
- ISRCTN88528808
- Lead Sponsor
- German Atrial Fibrillation Network
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 422
1. Documented paroxysmal atrial fibrillation: electrocardiogram (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
2. Age =18
3. Patient informed orally and in writing
4. Written informed consent of the patient
1. Strong clinical evidence for therapy with AT II/ACE inhibitors within the last month
2. Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodaron within the last 3 months
3. DC cardioversion within the last 3 months
4. Symptomatic bradycardia
5. Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
6. Cardiac surgery or cardiac catheter ablation within the last 3 months
7. Typical angina pectoris symptoms at rest or during exercise
8. Known coronary artery disease with indication for intervention
9. Valvular disease >II degree
10. Left ventricular ejection fraction <40%
11. Diastolic blood pressure >110 mmHg at rest
12. Symptomatic arterial hypotension
13. Known renal artery stenosis
14. Serum creatinine >1.8 mval/l
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method 1. Time to first occurrence of a documented relapse of atrial fibrillation<br>2. Time to first occurrence of a symptomatic documented episode of AF<br>3. Time to persistent atrial fibrillation<br>4. Time to prescription of the recovery-medication<br>5. Number of hospitalizations for cardiovascular reasons (-> Endpoint review)<br>6. Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization<br>7. Number of cerebrovascular events<br>8. Quality of life