Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrial Fibrillation Network; German Atrial Fibrillation Network
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Angiotensin II; Angiotensin Receptor Antagonists; Angiotensinogen; Olmesartan; Olmesartan Medoxomil

Criteria

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