Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation - Full Text View

Sponsor:	German Atrial Fibrillation Network
Collaborator:	Daiichi Sankyo Inc.
Information provided by:	German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:	NCT00098137

Purpose

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.

Condition	Intervention	Phase
Heart Disease Arrhythmia Atrial Fibrillation	Drug: olmesartanmedoxomil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Diseases

Drug Information available for: Angiotensin II Angiotensin II, ile(5)-

U.S. FDA Resources

Further study details as provided by German Atrial Fibrillation Network:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	422
Study Start Date:	January 2005
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098137

Sponsors and Collaborators

German Atrial Fibrillation Network

Daiichi Sankyo Inc.

Investigators

Principal Investigator:	Thomas Meinertz, MD	University Hospital Hamburg
Principal Investigator:	Andreas Goette, MD	University Hospital Magdeburg

More Information

Additional Information:

Homepage of the German AF Network This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	German Atrial Fibrillation Network ( Andreas Goette )
Study ID Numbers:	AFNET-B10, BMBF; Grant No 01GI0204
Study First Received:	December 3, 2004
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00098137 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:

atrial fibrillation
angiotensin II
angiotensin receptor antagonist
drug
controlled clinical trial

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases

Cardiovascular Agents
Atrial Fibrillation
Angiotensin II
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010