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

Phase 3
Completed
Conditions
Atrial Fibrillation
Interventions
Drug: Placebo
Registration Number
NCT00352560
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BPlacebo-
AIrbesartan-
Primary Outcome Measures
NameTimeMethod
Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.The measures are taken after 31 days of irbesartan treatment
Secondary Outcome Measures
NameTimeMethod
Irbesartan effect on A Function RPThe measures are taken after 31 days of irbesartan treatment
Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patientsThe measures are taken after 31 days of irbesartan treatment
Refractoriness dispersionThe measures are taken after 31 days of irbesartan treatment

Trial Locations

Locations (1)

Local Institution

🇪🇸

Madrid, Spain

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