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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225667
Recruitment Status : Unknown
Verified November 2005 by Connolly, Stuart, M.D..
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2005
Last Update Posted : November 23, 2005
Bristol-Myers Squibb
Information provided by:
Connolly, Stuart, M.D.

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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2005
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Sinus Node Dysfunction (with or without AV conduction disturbance)
  • Permanent, atrial or dual-chamber pacemaker implanted > 2 months before enrollment and with ability to record and store atrial high-rate episodes, frequency of mode switches and to perform non-invasive electrophysiologic testing
  • History of at least 6 AHRE in the last 6 months (rate > 220/min, duration of > 2 minutes
  • History of prior diagnosis of hypertension and/or treated for hypertension OR two documented BP > 130/85 (measurements done at least one week apart)

Exclusion Criteria:

  • Permanent or persistent AF or more than 6 episodes of symptomatic paroxysmal AF in the previous 6 months
  • Documented Cr >200 umol/L and K+ >5.2 mmol/L in the previous 3 months
  • Current treatment with a potassium sparing diuretic, unless serum potassium known to be in the normal range
  • LV ejection fraction known to be < 40 %
  • Moderate or severe mitral regurgitation (3+, 4 +)
  • Mitral stenosis of more than mild severity
  • Aortic stenosis with mean gradient of > 25 mmHg
  • Angina at rest in the last 2 months, or current CCS Class 3 or 4 angina
  • Unipolar atrial lead
  • Previous AV node ablation
  • P-wave amplitude less than 1.5 mV
  • Current therapy with an ACE inhibitor, ARB or aldosterone antagonist
  • Current or planned (within 6 months) with an anti-arrhythmic medication (amiodarone, sotalol, flecainide, propafenone, quinidine, dofetilide

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 identifier (NCT number): NCT00225667

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Contact: Stuart J. Connolly, MD 905-527-4322 ext 44563
Contact: Jeffrey S. Healey, MD 905-527-4322 ext 44789

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Canada, Ontario
Population Health Research Institute of McMaster University
Hamilton, Ontario, Canada, L8L 2X2
Contact: Ellison J. Themeles, MSc.    905-527-4322 ext 44713   
Principal Investigator: Stuart J. Connolly, MD         
Sponsors and Collaborators
Connolly, Stuart, M.D.
Bristol-Myers Squibb
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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
Layout table for additonal information Identifier: NCT00225667    
Other Study ID Numbers: 099104
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: November 23, 2005
Last Verified: November 2005
Keywords provided by Connolly, Stuart, M.D.:
Atrial Fibrillation
Pacemaker, Artificial
Atrial High Rate Episodes
Renin-Angiotensin System
Cardiac Remodeling
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Remodeling
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action