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

Tracking Information

First Received Date ^ICMJE

July 12, 2006

Last Updated Date

June 27, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00352560 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Irbesartan effect on A Function RP
Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients
Refractoriness dispersion

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Irbesartan
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00352560

Responsible Party

Study ID Numbers ^ICMJE

CV131-235

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Sanofi-Aventis

Investigators ^ICMJE

Study Director:

Miguel Angel Sanchez Zamorano, MD

Medical Department, Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP