Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
NCT ID: NCT00098137
Last Updated: 2012-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
422 participants
INTERVENTIONAL
2005-01-31
2009-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Olmesartan
Olmesartan tablet, 1 in the morning
Olmesartan
Placebo
Placebo tablets, 1 in the morning
Olmesartan
Interventions
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Olmesartan
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18
* Patient informed orally and in writing
* Written informed consent of the patient
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Atrial Fibrillation Network
OTHER
Responsible Party
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Principal Investigators
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Thomas Meinertz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Hamburg
Andreas Goette, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Magdeburg
Countries
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References
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von Eisenhart Rothe AF, Goette A, Kirchhof P, Breithardt G, Limbourg T, Calvert M, Baumert J, Ladwig KH. Depression in paroxysmal and persistent atrial fibrillation patients: a cross-sectional comparison of patients enroled in two large clinical trials. Europace. 2014 Jun;16(6):812-9. doi: 10.1093/europace/eut361. Epub 2013 Dec 18.
von Eisenhart Rothe A, Bielitzer M, Meinertz T, Limbourg T, Ladwig KH, Goette A. Predictors of discordance between physicians' and patients' appraisals of health-related quality of life in atrial fibrillation patients: findings from the Angiotensin II Antagonist in Paroxysmal Atrial Fibrillation Trial. Am Heart J. 2013 Sep;166(3):589-96. doi: 10.1016/j.ahj.2013.05.020. Epub 2013 Jul 10.
Goette A, Schon N, Kirchhof P, Breithardt G, Fetsch T, Hausler KG, Klein HU, Steinbeck G, Wegscheider K, Meinertz T. Angiotensin II-antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):43-51. doi: 10.1161/CIRCEP.111.965178. Epub 2011 Dec 7.
Related Links
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Homepage of the German AF Network
Other Identifiers
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Grant No 01GI0204
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AFNET-B10
Identifier Type: -
Identifier Source: org_study_id