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FAQs
- What is the CARE-HF Trial?
- What was the primary endpoint?
- What were the secondary endpoints?
- How many patients were enrolled in the trial, and at how many clinical centers?
- What were the inclusion criteria for CARE-HF?
- When did the trial start and end?
- What were the main highlights of the CARE-HF trial?
- How does CARE-HF differ from other CRT mortality trials?
- Based on the fact that CARE-HF showed CRT alone reduces mortality, is there value in using combined CRT-D devices?
- Why is CARE-HF such an important trial for the treatment of patients with heart failure?
- What other trials has Medtronic sponsored to evaluate the benefits of CRT?
- What Medtronic products were used in CARE-HF?
- What else is Medtronic doing to evaluate the benefits of CRT?
What is the CARE-HF Trial?
The CARE-HF trial is an international, open-label, randomized, and controlled trial that was sponsored by Medtronic to evaluate the effects of Cardiac Resynchronization Therapy (CRT) on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony already receiving optimal medical therapy.
What was the primary endpoint?
The primary endpoint was a composite of all-cause mortality or an unplanned cardiovascular hospitalization using a time to first event analysis.
What were the secondary endpoints?
The secondary endpoints included: All-cause mortality, unplanned hospitalization for or with worsening heart failure, NYHA classification, quality of life, patient status at the end of the study, and mechanistic outcomes.
How many patients were enrolled in the trial, and at how many clinical centers?
813 patients were enrolled at 82 clinical centers in 12 European countries. Patients were randomized to one of two groups: One group received CRT plus optimal medical therapy (n=409), and the other group received optimal medical therapy alone (n=404).
What were the inclusion criteria for CARE-HF?
Eligible patients had heart failure for at least six weeks, were in NYHA class III/IV, had a left ventricular ejection fraction of no more than 35%, cardiac dyssynchrony as indicated by QRS width of at least 120ms, and left ventricular end diastolic dimension of at least 30 mm in height. All patients were on optimal medical therapy.
When did the trial start and end?
Patient enrollment began in January 2001 and ended in March 2003. The protocol required a minimum follow-up period of 18 months. The study concluded on September 30, 2004. Results were announced at the American College of Cardiology (ACC) annual scientific session in March 2005 and published in the New England Journal of Medicine on April 14, 2005.
What were the main highlights of the CARE-HF trial?
The trial provided conclusive proof that CRT on top of optimal medical therapy significantly reduces the risk of death and hospitalizations among patients with moderate to severe heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony.
How does CARE-HF differ from other CRT mortality trials?
CARE-HF differs from other CRT mortality studies in that it is the only heart failure trial powered to assess the impact of cardiac resynchronization therapy (alone) on mortality and morbidity. In addition, it was prospectively designed to assess the endpoints from the time of enrollment, a true measure of the “intent-to-treat” nature of the study.
Based on the fact that CARE-HF showed CRT alone reduces mortality, is there value in using combined CRT-D devices?
Yes, despite CRT one third of deaths that occurred in CARE-HF were sudden. Adding a back-up defibrillator (CRT-D device) would have prevented many of these sudden deaths.
Why is CARE-HF such an important trial for the treatment of patients with heart failure?
Heart failure affects more than 22 million people worldwide, including 6 million in Europe and 5 million in the United States, with approximately 500,000 new patients diagnosed each year. It is the only cardiac condition that is increasing in prevalence, and it is a major cost and quality of life issue, characterized by frequent hospitalizations. The positive results from CARE-HF reinforce the need to routinely consider CRT as an adjunct to optimal medical therapy to improve patients’ quality of life, clinical status, and survival.
What other trials has Medtronic sponsored to evaluate the benefits of CRT?
Other major clinical trials sponsored by Medtronic include MUSTIC, MIRACLE and MIRACLE ICD. These trials showed dramatic benefits— including improved exercise capacity, quality of life and clinical symptoms— for many heart failure patients who receive cardiac resynchronization therapy.
What Medtronic products were used in CARE-HF?
Medtronic provided implantable cardiac resynchronization therapy devices from the InSync family, left ventricular cardiac vein leads from the Attain family, standard right chamber leads, and the cardiac resynchronization device programmer model 9790.
What else is Medtronic doing to evaluate the benefits of CRT?
Medtronic is supporting physicians in ongoing clinical studies, including the BLOCK HF and REVERSE studies, to determine if CRT can help additional groups of heart failure patients not currently eligible for the therapy.