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.
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
422
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)
Time frame: 12 months follow-up
Time to first occurrence of a documented relapse of atrial fibrillation
Time frame: 12 months follow up
Time to first occurrence of a symptomatic documented episode of AF
Time frame: 12 months follow up
Time to persistent atrial fibrillation
Time frame: 12 months follow up
Time to prescription of the recovery-medication
Time frame: 12 months follow up
Number of hospitalizations for cardiovascular reasons (-> Endpoint review)
Time frame: 12 months follow up
Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization
Time frame: 12 months follow up
Number of cerebrovascular events
Time frame: 12 months follow up
Quality of life
Time frame: 12 months follow up
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