Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098137
• Other study ID #: AFNET-B10
• Secondary ID: Grant No 01GI020
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2004
• Last updated: September 10, 2012
• Start date: January 2005
• Est. completion date: May 2009

Study information

• Verified date: September 2012
• Source: Atrial Fibrillation Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation
• Heart Disease
• Heart Diseases

Intervention

Drug:
• Olmesartan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Atrial Fibrillation Network	Daiichi Sankyo, Inc.

Outcome

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

External Links

•   Homepage of the German AF Network