Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Atrial Fibrillation Network (AFNET)

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Arrhythmia

Heart Disease

Treatments

Drug: Olmesartan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00098137

AFNET-B10

Grant No 01GI0204 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

422 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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