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

NCT ID: NCT00352560

Last Updated: 2010-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Irbesartan

Intervention Type DRUG

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

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Irbesartan

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Avapro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Principal Investigators

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Miguel Angel Sanchez Zamorano, MD

Role: STUDY_DIRECTOR

Medical Department, Bristol-Myers Squibb

Locations

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Local Institution

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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CV131-235

Identifier Type: -

Identifier Source: org_study_id

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