Paroxysmal Atrial Fibrillation Circulatory System Atrial fibrillation
Conditions
Interventions
Examination of the study hypothesis in a prospective, randomized, placebo-controlled, double-blind group comparison in patients with documented paroxysmal atrial fibrillation.
40 mg/day Olmesartanmedo
Sponsors
German Atrial Fibrillation Network
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 110 mmHg at rest 12. Symptomatic arterial hypotension 13. Known renal artery stenosis 14. Serum creatinine >1.8 mval/l
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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first occurrence of a documented relapse of atrial fibrillation 2. Time to first occurrence of a symptomatic documented episode of AF 3. Time to persistent atrial fibrillation 4. Time to prescription of the recovery-medication 5. Number of hospitalizations for cardiovascular reasons (-> Endpoint review) 6. Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization 7. Number of cerebrovascular events 8. Quality of life | — |
Countries
Germany
Outcome results
None listed