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Completed

NCT Number: NCT00098137

Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

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.

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Key information

Conditions

Heart Disease Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olmesartan

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to first occurrence of a documented relapse of atrial fibrillation

    Time frame: 12 months follow up

  2. Time to first occurrence of a symptomatic documented episode of AF

    Time frame: 12 months follow up

  3. Time to persistent atrial fibrillation

    Time frame: 12 months follow up

  4. Time to prescription of the recovery-medication

    Time frame: 12 months follow up

  5. Number of hospitalizations for cardiovascular reasons (-> Endpoint review)

    Time frame: 12 months follow up

  6. Number of intermediate medical visits for cardiovascular reasons (-> Endpoint review) without hospitalization

    Time frame: 12 months follow up

  7. Number of cerebrovascular events

    Time frame: 12 months follow up

  8. Quality of life

    Time frame: 12 months follow up

Sponsors and collaborators

Lead sponsor

Atrial Fibrillation Network

Other

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Dec 6, 2004
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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