NCT00098137

Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: Atrial Fibrillation Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.

Conditions

• Heart Disease
• Arrhythmia
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Olmesartan

Timeline

• Start date: 2005-01-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2004-12-06
• Last updated: 2012-09-11