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Care-HF CArdiac Resynchronization in Heart Failure

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ClinicalTrials.gov Identifier: NCT00170300
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center

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 receiving diuretics and optimal medical therapy.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Implantable Cardiac Resynchronisation (pacing) device Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 813 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
Study Start Date : January 2001
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. All cause mortality or unplanned cardiovascular hospitalization.

Secondary Outcome Measures :
  1. All cause mortality
  2. All cause mortality or unplanned hospitalization for or with worsening Heart Failure
  3. Days alive and not in hospital for unplanned cardiovascular cause
  4. Days alive and not in hospital for any reason
  5. NYHA class at 90 days
  6. QOL at 90 days
  7. End of study status
  8. MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
  9. HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170300


Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic
Investigators
Study Chair: John Cleland, Professor The University of Hull; Department of Cardiology; United Kingdom

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00170300     History of Changes
Other Study ID Numbers: Care-HF 2.02.02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Keywords provided by Medtronic Bakken Research Center:
Cardiac resynchronisation therapy (CRT therapy),
all-cause mortality,
quality of life assesment,
echocardiographic left ventricular function,
CRT and neurohormonal activation,
CRT and health economics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases