Care-HF CArdiac Resynchronization in Heart Failure
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The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Heart failure for at least 6 weeks requiring loop diuretics
Currently in NYHA class III/IV
A high standard of pharmacological therapy
LV systolic dysfunction and dilation (EF <=35%; EDD >30mm/height in metres)
QRS >=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall)
Age < 18 years old or age < legal age defined in the country in case different
Chronic atrial fibrillation within 6 weeks prior to randomization;
Impairment of left ventricular function not related to left ventricular systolic function
Potentially reversible forms of cardiomyopathy:
Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization
A conventional indication for bradyarrhythmia pacing exists;
A conventional indication for an ICD exists
A pacemaker or ICD has already been implanted;
In-Patients requiring continuous intravenous therapy for Heart Failure;
Life expectancy < 1 year for disease unrelated to Heart Failure;
Pregnancy or childbearing potential and not on reliable contraceptive;
Mechanical tricuspid valve;
Anticipated compliance problem or participation in another trial;