Medtronic
 
 

Heart Failure

CArdiac REsynchronization in Heart Failure Study (CARE-HF)

Protocol:

CArdiac REsynchronization in Heart Failure Study (CARE-HF)

Purpose:

To assess the effect on morbidity and mortality of adding CRT to optimized pharmacological therapy in patients with moderate and severe heart failure due to LV systolic dysfunction complicated by cardiac dyssynchrony.

Primary endpoint:

  • All-cause mortality or unplanned cardiovascular hospitalization. (Hospitalizations were adjudicated by a blinded end-point committee.)

Main secondary endpoint:

  • All-cause mortality, classified by mode and cause

Status:

Enrollment period: January 2001 to March 2003
Follow-up: 18 months minimum
Sample size: 813 patients

Results:

The study found that cardiac resynchronization therapy administered in combination with optimal medical therapy saves lives and reduces hospitalizations:

  • 37% reduction in combined all-cause mortality or unplanned cardiovascular hospitalizations
  • 36% reduction in all-cause mortality
  • 52% reduction in unplanned cardiovascular hospitalizations

CRT was found to improve cardiac function and structure, specifically CRT:

  • Provides sustained improvement in cardiac function and structure.
  • Improves systolic function
  • Reduces pro-BNP levels

 

References:
  1. Cleland JGF, Daubert J-C, Erdmann E, et al for the Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med 2005;352:1539-1549.
  2. Cleland JGF, Daubert J-C, Erdmann E, et al on behalf of the CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Euro J Heart Failure 2001;3: 481-489.
  3. J Cleland JGF, Daubert J-C, Erdmann E, et al on behalf of the CARE-HF study Steering Committee and Investigators. Baseline characteristics of patients recruited into the CARE-HF study. Euro J Heart Failure 2005; 7:205-214.
  4. Calverta MJ, Freemantlea TN, Cleland JGF. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Euro J Heart Failure 2005;7:243-251.
  5. Jarcho JA. Resynchronizing ventricular contraction in heart failure. N Engl J Med 2005;352:1594-1597.

 

For more information visit: www.care-hf.com

 

Additional Information