Status:
COMPLETED
Care-HF CArdiac Resynchronization in Heart Failure
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 rec...
Detailed Description
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT00170300
Start Date
January 1 2001
End Date
May 1 2005
Last Update
July 3 2025
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