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Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial

Completed
Conditions
Paroxysmal Atrial Fibrillation
Circulatory System
Atrial 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
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
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