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

Bristol-Myers Squibb44 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

IrbesartanDRUG

Tablets, Oral, 300 mg, once daily, 30 days.

PlaceboDRUG

Tablets, Oral, 0 mg, once daily, 30 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Local Institution

Madrid, Spain

Local Institution

Madrid, Spain

Local Institution

Madrid, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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