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September 11, 2003


Emory Cardiologist Heads National DECREASE-HF Study To Find Best Cardiac Resynchronization Therapy Mode For Heart Failure Patients

ATLANTA - Approved by the FDA in 2001, cardiac resynchronization therapy (CRT) has been hailed as the first major therapeutic breakthrough for people with serious congestive heart failure (CHF) since the development of specialized heart failure drugs.

Now a national study involving approximately 60 medical centers throughout the U.S., including Emory University Hospital (EUH) and Emory Crawford Long Hospital (ECLH), is researching the optimum way to program biventricular pacemakers to provide CHF patients with the best possible therapeutic benefits.

Nearly 5 million Americans are currently living with congestive heart failure CHF and approximately 550,000 new cases are diagnosed in the U.S. each year. "We know CRT is an important therapy for CHF that can help many people with this disease, but we need to find out how we can fine tune it," says Emory cardiologist David DeLurgio, MD, principal investigator for the national DECREASE-HF (Device Evaluation of CONTAK® RENEWAL™ 2 and EASYTRAK® 2: Assessment of Safety and Effectiveness in Heart Failure) study.

"The DECREASE-HF study will compare three different modes of resynchronization therapy and also a new resynchronization lead. The goal is to determine if different ways of programming the resynchronization have different effects. All of these modes deliver therapy, but we want to see if one is best, "says Dr. DeLurgio, MD, who is Director of the electrophysiology laboratory at Emory University School of Medicine in Atlanta.

The researchers are specifically studying Guidant Corporation's CONTAK RENEWAL 2 cardiac resynchronization therapy device and EASTYTRAK 2 lead. This is the first controlled study to examine the effects of left ventricular CRT or sequential biventricular CRT compared to simultaneous biventricular CRT for the treatment of heart failure.

The device is also an internal cardiac defibrillator ( ICD) which provides a shock capable of stopping potentially deadly arrhythmias. " Although the defibrillator itself is not part of the study nor the direct therapy , it is an important preventive therapy which has been proven to reduce the risk of death," Dr. DeLurgio notes. "There is no placebo arm to this study so all participants will receive an implanted CRT biventricular pacemaker and ICD."

Emory researchers have been at the forefront of researching and implanting biventricular pacemakers, which stimulate the heart's ventricles to beat at the same time and improve the heart's ability to increase blood flow to the body. In 1999, Dr. DeLurgio, Jonathan Langberg, MD, and Angel Leon, MD, performed Georgia's first implantation of a biventricular pacemaker at ECLH. Emory was one of 15 centers in the U.S. and Canada to test the device - developed by Medtronic - as part of the MIRACLE study. After the device received FDA approval, Angel Leon, MD, Chief of Cardiology at ECLH, performed Georgia's first implantation of a biventricular pacemaker CRT at Emory Crawford Long Hospital (ECLH) in 2001.

Since then, more than 800 biventricular pacemaker have been implanted in patients with CHF at Emory Hospitals -- more than at any other medical center in the world. Documented results have included a dramatic improvement in quality of life, exercise tolerance and heart function for many of these patients with CHF.

The Emory team of researchers is currently enrolling research subjects in the DECREASE-HF study who have CHF with a history of coronary disease and/or life threatening cardiac arrhythmias. Patients referred as possible DECREASE-HF participants will undergo an initial screening to determine eligibility based on specific criteria which include the degree of heart weaknes and electrocardiogram (EKG) findings. If selected as research subjects, they will be closely monitored following implantation of the biventricular pacemaker. For more information on possible participation in the study, contact research nurse Nikki Van Houten at 404-686-7450.

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