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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Irbesartan

Placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Patients with Paroxysmal Atrial Fibrillation (PAF)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.

Secondary Outcome Measures

Irbesartan effect on A Function RP

Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients

Refractoriness dispersion

Full Information

NCT ID

NCT00352560

First Posted

July 12, 2006

Last Updated

February 15, 2010

Sponsor

Bristol-Myers Squibb

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00352560

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

Collaborators

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Patients with Paroxysmal Atrial Fibrillation (PAF)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Irbesartan

Other Intervention Name(s)

Avapro

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Irbesartan effect on A Function RP

Time Frame

The measures are taken after 31 days of irbesartan treatment

Title

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

Title

Refractoriness dispersion

Time Frame

The measures are taken after 31 days of irbesartan treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miguel Angel Sanchez Zamorano, MD

Organizational Affiliation

Medical Department, Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Local Institution

City

Madrid

ZIP/Postal Code

28905

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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