Mayo Clinic to Study a New Treatment for People with Heart Failure

Monday, February 24, 2003

Mayo Clinic is seeking male and female volunteers age 18 or older who have been diagnosed with congestive heart failure (a weakness of the heart muscle). The purpose of this research study is to determine the effectiveness of Enhanced External Counter-Pulsation (EECP) in the treatment of patients with congestive heart failure versus treatment with medications alone. Nearly five million people in the United States have heart failure, with almost 500,000 newly diagnosed cases each year. People with congestive heart failure have hearts with reduced pumping ability, commonly caused after suffering a heart attack.

EECP is a non-invasive outpatient therapy for the treatment of cardiovascular diseases. The Food and Drug Administration recently cleared EECP for use in patients with congestive heart failure. During EECP, inflatable cuffs which are synchronized with the heart rhythm, compress the legs between heartbeats enhancing blood flow and oxygen supply to the heart and arteries. Just before the heart contracts, the cuffs deflate reducing the heart's workload.

"We routinely treat heart failure with standard medications," says Alfredo Clavell, M.D., a Mayo Clinic cardiologist and lead researcher for the study at Mayo. "In spite of this treatment, some patients may still have symptoms of heart failure, such as fatigue, shortness of breath, and swelling in the legs or abdomen. We have designed this study to see if these persisting symptoms, present in spite of optimal medical treatment, can be improved by the application of EECP," says Dr. Clavell.

Qualified subjects will be randomly assigned to receive either EECP or standard medical care. Participants randomized to receive EECP will return for therapy five days a week for a total of seven weeks, and then one week, three months and six months thereafter for a clinic visit. Participants randomized to the standard medical care group will also return for a one week, three month and six month follow-up visit. Overall, both groups will be followed for about nine months.

To obtain more information or to participate in this research study should call Kristine Osborn, at 507-266-3629.

Contact:
Richard D. Hurt, Jr.
507-284-5005 (days)
507-284-2511 (evenings)
e-mail: newsbureau@mayo.edu

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