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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

September 9, 2005
December 29, 2008
January 2001
Not Provided
All cause mortality or unplanned cardiovascular hospitalization.
Same as current
Complete list of historical versions of study NCT00170300 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Care-HF CArdiac Resynchronization in Heart Failure
Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With 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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
Device: Implantable Cardiac Resynchronisation (pacing) device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
813
May 2005
Not Provided

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00170300
Care-HF 2.02.02
Not Provided
Not Provided
Medtronic Bakken Research Center
Medtronic
Study Chair: John Cleland, Professor The University of Hull; Department of Cardiology; United Kingdom
Medtronic Bakken Research Center
September 2005

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