Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Phase 3

Completed

• Conditions: Heart Disease; Arrhythmia; Atrial Fibrillation
• Interventions: Drug: Olmesartan

• Registration Number: NCT00098137
• Lead Sponsor: Atrial Fibrillation Network

Brief 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.

Study Timeline

• Study First Submitted: 2004-12-03
• Study First Submitted QC: 2004-12-03
• Study First Posted: 2004-12-06
• Study Start: 2005-01
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-10
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 422

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Olmesartan	Placebo tablets, 1 in the morning
Olmesartan	Olmesartan	Olmesartan tablet, 1 in the morning

Primary Outcome Measures

Name	Time	Method
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)	12 months follow-up

Secondary Outcome Measures

Name	Time	Method
Number of hospitalizations for cardiovascular reasons (-> Endpoint review)	12 months follow up
Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization	12 months follow up
Time to persistent atrial fibrillation	12 months follow up
Time to prescription of the recovery-medication	12 months follow up
Time to first occurrence of a documented relapse of atrial fibrillation	12 months follow up
Time to first occurrence of a symptomatic documented episode of AF	12 months follow up
Number of cerebrovascular events	12 months follow up
Quality of life	12 months follow up