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

February 15, 2010 updated by: Bristol-Myers Squibb
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Local Institution
      • Madrid, Spain, 28040
        • Local Institution
      • Madrid, Spain, 28905
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Irbesartan
Tablets, Oral, 300 mg, once daily, 30 days.
Other Names:
  • Avapro
Placebo Comparator: B
Drug: Placebo
Tablets, Oral, 0 mg, once daily, 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The measures are taken after 31 days of irbesartan treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Irbesartan effect on A Function RP
Time Frame: The measures are taken after 31 days of irbesartan treatment
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
The measures are taken after 31 days of irbesartan treatment
Refractoriness dispersion
Time Frame: The measures are taken after 31 days of irbesartan treatment
The measures are taken after 31 days of irbesartan treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Sanofi

Investigators

  • Study Director: Miguel Angel Sanchez Zamorano, MD, Medical Department, Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 12, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2010

Last Update Submitted That Met QC Criteria

February 15, 2010

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV131-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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