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

Sponsor:	Bristol-Myers Squibb
Collaborator:	Sanofi-Aventis
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00352560

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Irbesartan Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Irbesartan

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	44
Study Start Date:	July 2006
Study Completion Date:	June 2007

Arms	Assigned Interventions
A: Active Comparator	Drug: Irbesartan Tablets, Oral, 300 mg, once daily, 30 days.
B: Placebo Comparator	Drug: Placebo Tablets, Oral, 0 mg, once daily, 30 days.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352560

Locations

Spain
Local Institution
Madrid, Spain, 28905
Local Institution
Madrid, Spain, 28046
Local Institution
Madrid, Spain, 28040

Sponsors and Collaborators

Bristol-Myers Squibb

Sanofi-Aventis

Investigators

Study Director:

Miguel Angel Sanchez Zamorano, MD

Medical Department, Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CV131-235
Study First Received:	July 12, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00352560 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:

Patients with Paroxysmal Atrial Fibrillation (PAF)

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Irbesartan

Cardiovascular Diseases
Cardiovascular Agents
Atrial Fibrillation
Antihypertensive Agents
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009