ISRCTN16587532
Completed
N/A
The addition of cardiac resynchronisation therapy to implantable cardioverter-defibrillator and optimal medical therapy to patients with mild to moderate congestive heart failure symptoms: a randomised controlled trial
niversity of Ottawa Heart Institute (Canada)0 sites1,800 target enrollmentNovember 18, 2005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Congestive heart failure
- Sponsor
- niversity of Ottawa Heart Institute (Canada)
- Enrollment
- 1800
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Amended 06/03/2009:
- •Point 2 has been removed: 'Aged greater than or equal to 30, either sex'.
- •Initial information at the time of registration:
- •1\. New York Heart Association (NYHA) class II
- •2\. Aged greater than or equal to 30 years old, either sex
- •3\. LVEF less than or equal to 30% by multiple gated acquisition (MUGA) scan or LVEF less than or equal to 30% and LV end diastolic dimension greater than 60 mm (by echocardiogram) within 6 months of randomisation
- •4\. QRS duration greater than or equal to 120 ms
- •5\. Optimal heart failure pharmacological therapy
- •6\. ICD indication for primary or secondary prevention
- •7\. Normal sinus rhythm OR chronic persistent atrial fibrillation with resting ventricular heart rate less than or equal to 60 bpm and ventricular rate less than or equal to 90 bpm during a 6\-minute hall walk. This can be accomplished by pharmacological therapy or catheter AV Junction Ablation.
Exclusion Criteria
- •1\. In hospital patients who have acute cardiac or non\-cardiac cause
- •2\. Intra\-venous inotropic agent in the last 4 days
- •3\. Patients with a life expectancy of less than 1 year non\-cardiac cause
- •4\. Expected to under go cardiac transplantation within 1 year (status I)
- •5\. Patients with an acute coronary syndrome including myocardial infarction (MI) can be included if the patient has had a previous MI with LV dysfunction (LVEF less than or equal to 30%)
- •6\. Unable or unwilling to provide informed consent
- •7\. History of noncompliance of medical therapy
- •8\. Uncorrected or uncorrectable primary valvular disease
- •9\. Restrictive, hypertrophic or reversible form of cardiomyopathy
- •10\. Severe primary pulmonary disease such as cor pulmonale
Outcomes
Primary Outcomes
Not specified
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