The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points.
BACKGROUND
Cardiac resynchronisation is a promising new intervention for patients with heart failure, left ventricular systolic dysfunction and ventricular dyssynchrony.


OBJECTIVE
The CARE-HF trial is designed to evaluate the long-term effects of cardiac (atrio-bi-ventricular) resynchronisation on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy with ACE inhibitors and beta-blockers (where indicated and tolerated).


RESULTS
Approximately 800 patients will be randomised to device therapy or control and followed for a minimum of 18 months. A pragmatic study design has been chosen that does not attempt to conceal allocation from investigators or patients because it is impossible to guarantee maintenance of blinding for the duration of the study. The end-points committee will adjudicate events in a blinded fashion. Since cardiac resynchronisation may alter other aspects of the management of the patient, as would occur in clinical practice, the study should be considered a comparison of strategies rather than simply of a device. The primary end-point is all-cause mortality or unplanned cardiovascular hospitalisation. The study should complete recruitment during 2002 and report in 2004.
Cleland
J G
JG
Department of Cardiology, Castle Hill Hospital, Castle Road, Cottingham, University of Hull, Kingston upon Hull, HU16 5JQ, UK. j.g.cleland@hull.ac.uk
Daubert
J C
JC
Erdmann
E
E
Freemantle
N
N
Gras
D
D
Kappenberger
L
L
Klein
W
W
Tavazzi
L
L
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D002423:Cause of Death; D004452:Echocardiography; D004562:Electrocardiography; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D011379:Prognosis; D016016:Proportional Hazards Models; D012016:Reference Values; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D016019:Survival Analysis; D016896:Treatment Outcome; D006113:United Kingdom; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors