Care-HF CArdiac Resynchronization in Heart Failure
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure|
- All cause mortality or unplanned cardiovascular hospitalization.
- All cause mortality
- All cause mortality or unplanned hospitalization for or with worsening Heart Failure
- Days alive and not in hospital for unplanned cardiovascular cause
- Days alive and not in hospital for any reason
- NYHA class at 90 days
- QOL at 90 days
- End of study status
- MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
- HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.
|Study Start Date:||January 2001|
|Estimated Study Completion Date:||May 2005|
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170300
|Study Chair:||John Cleland, Professor||The University of Hull; Department of Cardiology; United Kingdom|