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

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ClinicalTrials.gov 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
Sponsor:
Collaborators:
Sanofi
Bristol-Myers Squibb
Information provided by:
Connolly, Stuart, M.D.

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 26, 2005
Last Update Posted Date November 23, 2005
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Time to recurrent AHRE ( 220/min for > 2 minutes)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • - 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
Official Title  ICMJE Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Hypertension
Intervention  ICMJE Drug: Irbesartan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 12, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00225667
Other Study ID Numbers  ICMJE 099104
CTA-099104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Connolly, Stuart, M.D.
Collaborators  ICMJE
  • Sanofi
  • Bristol-Myers Squibb
Investigators  ICMJE
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
PRS Account Connolly, Stuart, M.D.
Verification Date November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP