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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00352560
• Other study ID #: CV131-235
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2006
• Last updated: February 15, 2010
• Start date: July 2006
• Est. completion date: June 2007

Study information

• Verified date: June 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Irbesartan
Tablets, Oral, 300 mg, once daily, 30 days.
• Placebo
Tablets, Oral, 0 mg, once daily, 30 days.

Locations

Country	Name	City	State
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irbesartan effect on duration of Atrial Effective Refractory Period (AERP) in paroxysmal AF (PAF) patients.		The measures are taken after 31 days of irbesartan treatment
Secondary	Irbesartan effect on A Function RP		The measures are taken after 31 days of irbesartan treatment
Secondary	Irbesartan effect on atrial conduction intervals after basal & extra-stimuli, in PAF patients		The measures are taken after 31 days of irbesartan treatment
Secondary	Refractoriness dispersion		The measures are taken after 31 days of irbesartan treatment

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm