Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Official Title: “Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)”

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.

Double-blind, central randomization, two treatment groups, stratified by beta-blocker use.

211 patients in each treatment arm.

Intervention(s) in this Clinical Trial

• Drug: olmesartanmedoxomil

Primary Measures

• 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)
  • Time Frame: 12 months follow-up
    Safety Issue?: No

Secondary Measures

• Time to first occurrence of a documented relapse of atrial fibrillation
  • Time Frame: 12 months follow up
    Safety Issue?: No
• Time to first occurrence of a symptomatic documented episode of AF
  • Time Frame: 12 months follow up
    Safety Issue?: No
• Time to persistent atrial fibrillation
  • Time Frame: 12 months follow up
    Safety Issue?: No
• Time to prescription of the recovery-medication
  • Time Frame: 12 months follow up
    Safety Issue?: No
• Number of hospitalizations for cardiovascular reasons (-> Endpoint review)
  • Time Frame: 12 months follow up
    Safety Issue?: Yes
• Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization
  • Time Frame: 12 months follow up
    Safety Issue?: Yes
• Number of cerebrovascular events
  • Time Frame: 12 months follow up
    Safety Issue?: Yes
• Quality of life
  • Time Frame: 12 months follow up
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: German Atrial Fibrillation Network Other

Overall Clinical Trial Officials and Contacts

Thomas Meinertz, MD Principal Investigator University Hospital Hamburg  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00098137

Study ID Number: AFNET-B10

ClinicalTrials.gov Identifier: NCT00098137

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Homepage of the German AF Network