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

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ClinicalTrials.gov Identifier: NCT00352560
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : February 17, 2010
Sponsor:
Collaborator:
Sanofi
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Irbesartan Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Study Start Date : July 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: Irbesartan
Tablets, Oral, 300 mg, once daily, 30 days.
Other Name: Avapro
Placebo Comparator: B Drug: Placebo
Tablets, Oral, 0 mg, once daily, 30 days.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352560


Locations
Spain
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28046
Local Institution
Madrid, Spain, 28905
Sponsors and Collaborators
Bristol-Myers Squibb
Sanofi
Investigators
Study Director: Miguel Angel Sanchez Zamorano, MD Medical Department, Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00352560     History of Changes
Other Study ID Numbers: CV131-235
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: June 2008

Keywords provided by Bristol-Myers Squibb:
Patients with Paroxysmal Atrial Fibrillation (PAF)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action