Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Information source: German Atrial Fibrillation Network
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease; Arrhythmia; Atrial Fibrillation
Intervention: Olmesartan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: German Atrial Fibrillation Network Official(s) and/or principal investigator(s): Thomas Meinertz, MD, Principal Investigator, Affiliation: University Hospital Hamburg Andreas Goette, MD, Principal Investigator, Affiliation: University Hospital Magdeburg
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.
Clinical Details
Official title: Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: Time to first occurrence of a documented relapse of atrial fibrillationTime to first occurrence of a symptomatic documented episode of AF Time to persistent atrial fibrillation Time to prescription of the recovery-medication Number of hospitalizations for cardiovascular reasons (-> Endpoint review) Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization Number of cerebrovascular events Quality of life
Detailed description:
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use.
211 patients in each treatment arm.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Homepage of the German AF Network
Starting date: January 2005
Last updated: September 10, 2012
|