Care-HF CArdiac Resynchronization in Heart Failure

Study Overview
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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.

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)

Official Title
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Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Implantable Cardiac Resynchronisation (pacing) device


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implantable Cardiac Resynchronisation (pacing) device|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality or unplanned cardiovascular hospitalization. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac resynchronisation therapy (CRT therapy),, all-cause mortality,, quality of life assesment,, echocardiographic left ventricular function,, CRT and neurohormonal activation,, CRT and health economics