Title
Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)
Phase
Phase 3Lead Sponsor
German Atrial Fibrillation NetworkStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Heart Disease Arrhythmia Atrial FibrillationIntervention/Treatment
olmesartan ...Study Participants
422Hypothesis:
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.
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