Mayo Clinic to investigate new cardiovascular procedure to restore active lifestyle to patients with congestive heart failure

Tuesday, April 29, 2008

SCOTTSDALE, Ariz. – Patients with congestive heart failure (CHF) typically experience fatigue and shortness of breath, limiting their ability to lead the active lifestyle they enjoyed prior to developing heart disease. As part of a multicenter trial sponsored by Bioheart, Inc., Mayo Clinic is investigating a new cell implantation procedure that could potentially return all or part of their former vitality. Mayo is the first center in the Southwest enrolling patients in this study.

The study will examine whether a special type of rejuvenating cell from the patient's own body (skeletal myoblast) can replace lost cardiac muscle. David Fortuin, M.D., an interventional cardiologist, and colleagues are exploring the benefits of transplanting skeletal myoblast cells directly into the heart as a way of replacing lost muscle and re-strengthening the heart.

Myoblasts are specialized skeletal muscle cells known for their ability to renew muscle tissue. If the study can confirm improved heart strength and efficiency after implantation, patients with congestive heart failure can be given improved cardiac function—and an increased chance of resuming the physical activities of their previous life.

In many patients with congestive heart failure, their problem started with loss of blood flow from constricted or blocked arteries which causes heart muscle to die (a heart attack). The resulting scar tissue does not beat (as did the muscle before the heart attack), so the heart's ability to pump oxygen-rich blood to the body is severely restricted. "The heart is not traditionally thought of as a self-renewing organ, so once it's damaged, it can't regenerate itself," says Dr. Fortuin. "Scar tissue doesn't contract, so blood flow to the entire body is restricted and the heart can't keep up with the demands of the body."

As part of the study, myoblast cells will be removed from the patient's thigh area in a simple outpatient procedure. After being cultured and prepared for implantation, the cells will be introduced into the heart in a procedure similar to a cardiac catheterization. Participating patients will receive either one of two doses of myoblast cells or a placebo. Results will then be tracked and analyzed.

"We're hoping people whose lives have been limited because of heart disease will be able to resume the activities they enjoyed before their heart attacks," says Dr. Fortuin.

To be enrolled in the study, patients must have congestive heart failure resulting from a heart attack and experience restricted daily activities due to shortness of breath and fatigue. Participants must be receiving medical therapy for their condition and be in stable condition. Each will receive a complete baseline physical examination, full medical history and medication review, various screening tests and medical monitoring for a period of at least six months. To enroll in the study, contact Kellye Wagner at 480-342-2922. Nationally, more than 5.2 million Americans have congestive heart failure and 550,000 new cases are diagnosed each year. CHF is now the leading cause of hospitalization in people older than 65.

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Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. As a leading academic medical center in the Southwest, Mayo Clinic focuses on providing specialty and surgical care in more than 65 disciplines at its outpatient facility in north Scottsdale and at Mayo Clinic Hospital. The 244-licensed bed hospital is located at 56th Street and Mayo Boulevard (north of Bell Road) in northeast Phoenix, and provides inpatient care to support the medical and surgical specialties of the clinic, which is located at 134th Street and Shea Boulevard in Scottsdale.

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