Title of Trial
Cardiac Resnchronization Heart Failure (CARE-HF) Trial
Initial Presentation
Not yet presented
Date and Citation of Primary Publication(s) or References
Not yet presented
Purpose of the Trial
Evaluate the effects of cardiac resynchronization therapy in chronic heart failure on mortality and hospitalization.
Study Category
Pacing
Patient Population
Inclusion Criteria
Class III or IV heart failure, left ventricular ejection fraction < 0.35, left ventricular end diastolic volume > 55 mm, QRS interval > 150 ms, or QRS > 120 ms with echocardiographic parameters.
Study Design
Randomized controlled trial
Primary Endpoints
Composite of mortality and unplanned cardiovascular hospitalization
Secondary Endpoints
All cause mortality, days alive, quality-of-life, NYHA class
Baseline Characteristics
Patient number: 814 patients enrolled
Mean Age: ?
Gender: ?
Other characteristics: ?
Time to Follow-up
18 months planned follow-up
Results
Not available. Enrollment completed in March 2003.
Sponsor
Medtronic
Trial Status
Enrollment has completed, follow-up will be completed in September 2004