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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Irbesartan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352560

CV131-235

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Irbesartan

B

Placebo Comparator group

Treatment:

Drug: Placebo