Status:
UNKNOWN
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
Lead Sponsor:
Connolly, Stuart, M.D.
Collaborating Sponsors:
Sanofi
Bristol-Myers Squibb
Conditions:
Atrial Fibrillation
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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, know...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00225667
Start Date
December 1 2005
End Date
July 1 2007
Last Update
November 23 2005
Active Locations (1)
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1
Population Health Research Institute of McMaster University
Hamilton, Ontario, Canada, L8L 2X2