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

November 22, 2005 updated by: Connolly, Stuart, M.D.

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

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 Overview

Status

Unknown

Intervention / Treatment

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

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stuart J. Connolly, MD
  • Phone Number: 44563 905-527-4322
  • Email: connostu@hhsc.ca

Study Contact Backup

  • Name: Jeffrey S. Healey, MD
  • Phone Number: 44789 905-527-4322
  • Email: healeyj@hhsc.ca

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Population Health Research Institute of McMaster University
        • Contact:
        • Principal Investigator:
          • Stuart J. Connolly, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to recurrent AHRE ( 220/min for > 2 minutes)

Secondary Outcome Measures

Outcome Measure
- 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion

July 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

November 23, 2005

Last Update Submitted That Met QC Criteria

November 22, 2005

Last Verified

November 1, 2005

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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