The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo...
Date First Received: July 12, 2006
Last Updated: June 27, 2008
Verified by: Bristol-Myers Squibb, June 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2006
Overall Status: Completed
Estimated Enrollment: 44
Brief Summary
Official Title: “Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)”
Condition Keyword(s):
Intervention(s):
The main purpose of the study is to compare the mean AERP between treatment groups based on the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to placebo.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Irbesartan
- Tablets, Oral, 300 mg, once daily, 30 days.
- Drug: Placebo
- Tablets, Oral, 0 mg, once daily, 30 days.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: A
- Placebo Comparator: B
Outcome Measures for this Clinical Trial
Primary Measures
- Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Time Frame: The measures are taken after 31 days of irbesartan treatment
Secondary Measures
- Irbesartan effect on A Function RP
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Refractoriness dispersion
- Time Frame: The measures are taken after 31 days of irbesartan treatment
- Time Frame: The measures are taken after 31 days of irbesartan treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Recurrent PAF with indication for catheter ablation
Exclusion Criteria:
- Struct. Cardiopathy
- Mitral valve disease
- VEF<40%
- Myocardiopathy
- LVH
- cardiac surgery
- AF reversible
- QT c>450
- Recent MI/stroke, severe HTN
- Requirement of ACEI/ARBs
- Coronary synd., HTA, liver disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bristol-Myers Squibb
Overall Clinical Trial Officials and Contacts
Miguel Angel Sanchez Zamorano, MD Study Director Medical Department, Bristol-Myers Squibb
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00352560
Study ID Number: CV131-235
ClinicalTrials.gov Identifier: NCT00352560
Health Authority: Spain: Spanish Agency of Medicines
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