Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation|
- Time to recurrent AHRE ( 220/min for > 2 minutes)
- - 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.
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||July 2007|
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.
|Contact: Stuart J. Connolly, MD||905-527-4322 ext firstname.lastname@example.org|
|Contact: Jeffrey S. Healey, MD||905-527-4322 ext email@example.com|
|Population Health Research Institute of McMaster University||Not yet recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Ellison J. Themeles, MSc. 905-527-4322 ext 44713 firstname.lastname@example.org|
|Principal Investigator: Stuart J. Connolly, MD|
|Principal Investigator:||Stuart J. Connolly, MD||McMaster University|
|Principal Investigator:||Jeffrey S Healey, MD||McMaster University|
|Principal Investigator:||Carlos A Morillo, MD||McMaster University|
|Principal Investigator:||Stefan H Hohnloser, MD||J.W. Goethe University, Frankfurt Germany|
|Principal Investigator:||Carsten W Israel, MD||J.W. Goethe University, Frankfurt Germany|