Status:
COMPLETED
Trial to Investigate the Efficacy of Olmesartan in Paroxysmal Atrial Fibrillation
Lead Sponsor:
Atrial Fibrillation Network
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Heart Disease
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Double-blind, central randomization, two treatment groups, stratified by beta-blocker use. 211 patients in each treatment arm.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT00098137
Start Date
January 1 2005
End Date
May 1 2009
Last Update
September 11 2012
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