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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00352560
First received: July 12, 2006
Last updated: February 15, 2010
Last verified: June 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: Irbesartan
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Resource links provided by NLM:

Drug Information available for: Irbesartan
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome 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 Outcome 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 ]

Estimated Enrollment: 44
Study Start Date: July 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Irbesartan
Tablets, Oral, 300 mg, once daily, 30 days.
Other Name: Avapro
Placebo Comparator: B Drug: Placebo
Tablets, Oral, 0 mg, once daily, 30 days.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352560

Locations
Spain
Local Institution
Madrid, Spain, 28905
Local Institution
Madrid, Spain, 28046
Local Institution
Madrid, Spain, 28040
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
Study Director: Miguel Angel Sanchez Zamorano, MD Medical Department, Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00352560     History of Changes
Other Study ID Numbers: CV131-235
Study First Received: July 12, 2006
Last Updated: February 15, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:
Patients with Paroxysmal Atrial Fibrillation (PAF)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Irbesartan
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013