New Clinical Trial for Treatment Option for Heart Failure

Heart Failure is Nation's Most Rapidly Growing Cardiovascular Disease

Contact: Pat Samson (513) 585-7200
Date: 02/14/2001

Cincinnati--Physicians at The University Hospital are taking part in a multi-center clinical study to evaluate new treatment options for patients with heart failure, a progressive cardiovascular disorder that effects more than five million Americans.

In heart failure, the heart is unable to pump enough blood to meet the needs of the body. This year, nearly 400,000 new cases of heart failure will be diagnosed in the U.S., and the condition will claim more than a quarter million lives. Physicians typically treat heart failure with medications and advise the patient follow a recommended diet and exercise plan to manage symptoms like fatigue, shortness of breath, fluid retention and exercise intolerance.

The COMPANION investigational study, will involve up to 2,200 patients in 80 medical centers across the U.S. At The University Hospital, COMPANION is being led by cardiologist Santosh Menon, M.D. The study will evaluate the effectiveness of standard drug regimes alone or in combination with the implanted Guidant medical devices. The devices are designed to resynchronize the heart's contractions, producing a more effective pumping action and are manufactured by the Guidant Corporation, a leader in implantable medical devices. "These devices offer the potential to relieve symptoms and positively affect the lives of heart failure patients who, at this time, have few alternatives," says Menon.

Participants in the COMPANION study will be assigned randomly to one of three treatment groups to assess the success of drug therapy alone; or to the Guidant CONTAK TR with drug therapy, or to drug therapy and Guidant's CONTAK CD heart failure device which is designed to provide cardiac resynchronization plus therapy for irregular or dangerously fast heartbeats. Patients randomized to receive a CONTAK heart failure system will undergo a surgical procedure to implant the device; like the implanting of a pacemaker.

"Patients involved in the study will see their doctors at least every three months," says Menon. "During these visits, we collect data and perform special tests to evaluate how effectively the treatment is working." The study is expected to take three to four years complete. Heart failure patients in the Cincinnati area can get more information about the COMPANION study by calling The University Hospital at 513-584-0323.

The University Hospital is part of the Health Alliance. The Health Alliance is an integrated health care delivery system, which includes The Christ Hospital, The University Hospital, The St. Luke Hospitals, The Jewish Hospital, The Fort Hamilton Hospital and the physicians of Alliance Primary Care. </font></p>