NCT Number: NCT00170300
Care-HF CArdiac Resynchronization in Heart Failure
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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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
Primary outcomes
-
All cause mortality or unplanned cardiovascular hospitalization.
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Industry
Collaborators
- Medtronic
Registry information
Official study title
Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
Important dates
- Study start
- 2001
- Study completion
- 2005
- First posted
- Sep 15, 2005
- Registry last updated
- Jul 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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