Care-HF CArdiac Resynchronization in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00170300
First received: September 9, 2005
Last updated: December 29, 2008
Last verified: September 2005
  Purpose

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 Intervention
Heart Failure
Device: Implantable Cardiac Resynchronisation (pacing) device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 813
Study Start Date: January 2001
Estimated Study Completion Date: May 2005
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170300

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

Additional Information:
No publications provided by Medtronic Bakken Research Center

Additional 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
Study First Received: September 9, 2005
Last Updated: December 29, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014