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Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT00098137
Recruitment Status : Completed
First Posted : December 6, 2004
Last Update Posted : September 11, 2012
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Atrial Fibrillation Network

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Heart Disease Arrhythmia Atrial Fibrillation Drug: Olmesartan Phase 3

Detailed Description:
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial)
Study Start Date : January 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Olmesartan
Olmesartan tablet, 1 in the morning
 Drug: Olmesartan
Placebo Comparator: Placebo
Placebo tablets, 1 in the morning
 Drug: Olmesartan


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00098137


Sponsors and Collaborators
Atrial Fibrillation Network
Daiichi Sankyo, Inc.
Investigators
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Principal Investigator: Thomas Meinertz, MD University Hospital Hamburg
Principal Investigator: Andreas Goette, MD University Hospital Magdeburg
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00098137    
Other Study ID Numbers: AFNET-B10
Grant No 01GI0204 ( Other Grant/Funding Number: BMBF )
First Posted: December 6, 2004    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012
Keywords provided by Atrial Fibrillation Network:
atrial fibrillation
angiotensin II
angiotensin receptor antagonist
drug
controlled clinical trial
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
 Olmesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action