Clinical Trial: Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing A

Brief Summary: The purpose of this study is to determine whether irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker.

Detailed Summary:

Patients with permanent pacemakers have a high risk of atrial fibrillation (AF), particularly those with hypertension, sinus node dysfunction, and those with short episodes of atrial arrhythmias, known as atrial high-rate episodes (AHRE). AHRE are felt to be a precursor to AF, and may be both the result and a cause of changs in the atrial electrophysiology, and structure (known as cardiac remodeling)that are associated with the development of AF.

Evaluating this process in human AF has been limited by the cumbersome nature of performing serial, invasive electrophysiologic studies. However, modern pacemakers now permit rapid, non-invasive electrophysiologic testing and can also accurately document AHRE, which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF. In addition, this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling.

Comparison: Irbesartan compared to placebo.


Sponsor: Connolly, Stuart, M.D.

Current Primary Outcome: Time to recurrent AHRE ( 220/min for > 2 minutes)

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • - Frequency of AHRE’s (> 220/min for > 2 minutes) Evaluated at randomization, month 1 and 6.
  • - Development of sustained AF (>30 minutes), documented
  • by ECG, holter, rhythm strip or pacemaker electrograms
  • - Electrical Remodeling (AERP,SNRT,paced/sensed p-wave
  • duration). Evaluated at randomization, months 1 and 6.
  • - Markers of Inflammation (Plasma CRP,TNF-alpha, D-Dimer,
  • IL-6, Pro-collagen-III products, BNP,MPO,hsP). Blood collection at randomization and month 6.
  • - Structural Remodeling (left atrial volume, left
  • ventricular mass, left ventricular diastolic function. Evaluated at randomization and month 6.


Original Secondary Outcome: Same as current

Information By: Connolly, Stuart, M.D.

Dates:
Date Received: September 12, 2005
Date Started: December 2005
Date Completion: July 2007
Last Updated: November 22, 2005
Last Verified: November 2005