Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Verified by: Bristol-Myers Squibb, June 2008
First Received: July 12, 2006 | Last Updated: February 15, 2010 | Phase: Phase 3 | Start Date: July 2006
Overall Status: Completed | Estimated Enrollment: 44
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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...

Brief Summary

Official Title: “Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2007

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

Secondary Measures

  • Irbesartan effect on A Function RP
    • 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
  • Refractoriness dispersion
    • 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 Investigator Information

Lead Investigator: Bristol-Myers Squibb Industry

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 February 09, 2012

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

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

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