Status:
COMPLETED
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Medtronic
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significant public hea...
Detailed Description
Cardiovascular mortality is decreasing in most industrial countries, however mortality for congestive heart failure is increasing. The most important predictors of mortality in heart failure patients ...
Eligibility Criteria
Inclusion
- New York Heart Association (NYHA) Class II
- Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end diastolic dimension ≥ 60 mm (by echocardiogram) within 6 months prior to randomization
- Intrinsic QRS complex width ≥ 120 ms OR paced QRS measurement ≥ 200 ms
- ICD indication for primary or secondary prevention
- Optimal heart failure pharmacological therapy
- Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate ≤ 60 beats per minute (bpm) and 6 minute hall walk ventricular heart rate of ≤ 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting ventricular heart rate \> 60 bpm and 6 minute hall walk ventricular heart rate of \> 90 bpm and booked for atrioventricular junction ablation.
Exclusion
- Intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of less than one year from non-cardiac cause
- Expected to undergo cardiac transplantation within one year (status I)
- In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
- Uncorrected or uncorrectable primary valvular disease
- Restrictive, hypertrophic, or reversible form of cardiomyopathy
- Severe primary pulmonary disease such as cor pulmonale
- Tricuspid prosthetic valve
- Patients with an existing ICD (patients with an existing pacemaker may be included if the patients satisfy all other inclusion/exclusion criteria)
- Coronary revascularization (coronary artery bypass graft surgery \[CABG\] or percutaneous coronary intervention \[PCI\]) \< 1 month if previously determined LVEF \> 30%. Patients with a more recent revascularization can be included if a previously determined LVEF was ≤ 30%.
- Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patients have had a previous MI with LV dysfunction (LVEF ≤ 30%).
- Patients included in another clinical trial that will affect the objectives of this study
- History of noncompliance to medical therapy
- Unable or unwilling to provide informed consent
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1798 Patients enrolled
Trial Details
Trial ID
NCT00251251
Start Date
April 1 2003
End Date
May 1 2011
Last Update
August 28 2023
Active Locations (33)
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1
Royal Adelaide Hospital
Adelaide, Australia, 5000
2
Sir Charles Gairdner Hospital
Perth, Australia, 6009
3
University Ziekenhuis
Leuven, Belgium
4
University of Calgary/Foothill Hospital
Calgary, Alberta, Canada, T2N 2T9