The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points

Details

Serval ID
serval:BIB_0586D1D3AB28
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points
Journal
European Journal of Heart Failure
Author(s)
Cleland  J. G., Daubert  J. C., Erdmann  E., Freemantle  N., Gras  D., Kappenberger  L., Klein  W., Tavazzi  L.
ISSN
1388-9842 (Print)
Publication state
Published
Issued date
08/2001
Volume
3
Number
4
Pages
481-9
Notes
Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial --- Old month value: Aug
Abstract
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). METHODS AND 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.
Keywords
Adrenergic beta-Antagonists/administration & dosage Angiotensin-Converting Enzyme Inhibitors/administration & dosage *Cause of Death Echocardiography Electrocardiography Female Great Britain Heart Failure, Congestive/diagnosis/*mortality/*therapy *Heart-Assist Devices Humans Male Prognosis Proportional Hazards Models Reference Values Sensitivity and Specificity Severity of Illness Index Survival Analysis Treatment Outcome Ventricular Dysfunction, Left/diagnosis/*mortality/*therapy
Pubmed
Web of science
Create date
15/02/2008 11:28
Last modification date
20/08/2019 12:27
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