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OpenTrials
Completed

NCT Number: NCT00352560

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irbesartan

Drug

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

Other names: Avapro

Placebo

Drug

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

Primary outcomes

  1. 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 outcomes

  1. Irbesartan effect on A Function RP

    Time frame: The measures are taken after 31 days of irbesartan treatment

  2. 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

  3. Refractoriness dispersion

    Time frame: The measures are taken after 31 days of irbesartan treatment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Sanofi

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 14, 2006
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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