Care-HF CArdiac Resynchronization in Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

813 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-05-31

Brief Summary

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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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Detailed Description

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813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Implantable Cardiac Resynchronisation (pacing) device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No