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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 fibrillation

Time 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

Page last updated: August 23, 2015

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