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Care-HF CArdiac Resynchronization in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 30, 2018
Study Start Date  ICMJE January 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
All cause mortality or unplanned cardiovascular hospitalization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Care-HF CArdiac Resynchronization in Heart Failure
Official Title  ICMJE Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: Implantable Cardiac Resynchronisation (pacing) device
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
813
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00170300
Other Study ID Numbers  ICMJE Care-HF 2.02.02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Medtronic Bakken Research Center
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Study Chair: John Cleland, Professor The University of Hull; Department of Cardiology; United Kingdom
PRS Account Medtronic Bakken Research Center
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP