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

July 12, 2006
February 15, 2010
July 2006
June 2007   (final data collection date for primary outcome measure)
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 ]
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.
Complete list of historical versions of study NCT00352560 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Irbesartan effect on A Function RP
  • Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
  • Refractoriness dispersion
Not Provided
Not Provided
 
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: Irbesartan
    Tablets, Oral, 300 mg, once daily, 30 days.
    Other Name: Avapro
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 30 days.
  • Active Comparator: A
    Intervention: Drug: Irbesartan
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00352560
CV131-235
Not Provided
Not Provided
Bristol-Myers Squibb
Sanofi
Study Director: Miguel Angel Sanchez Zamorano, MD Medical Department, Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP