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
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.