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DURHAM, N.C. -- A new $37 million trial could determine
definitively whether a tailored exercise program can help heart
failure patients live longer. The trial is sponsored by the
National Heart Lung Blood Institute, a part of the National
Institutes of Health (NIH), and is coordinated by Duke
University Medical Center cardiologists.

While many trials conducted during the past decade have
shown that exercise can have a positive effect on symptoms
suffered by heart failure patients, the five-year,
3,000-patient randomized trial, to be conducted at more than 50
U.S. and Canadian hospitals, will be the first such large-scale
prospective trial designed to determine whether exercise can
reduce mortality for patients with heart failure or any other
disease, the researchers say.

Just as importantly, since heart failure patients tend to be
frequently admitted to the hospital, the researchers also want
to know if exercise has any effect on reducing
hospitalizations.

"Smaller studies over the past 10 years have shown that
exercise can do good things for heart failure patients, such as
reduce levels of harmful hormones and improve physical
activity," said Duke cardiologist Christopher O'Connor, M.D.,
principal investigator for the new trial. "However, these
studies weren't designed to uncover an effect on mortality and
morbidity.

"The history of heart failure research provides many
examples of pharmacologic treatments that appeared in early
trials to be beneficial, only to find that larger trials would
show a detrimental effect when mortality and morbidity was the
key endpoint," he added. "If exercise proves to have a
beneficial effect on these clinical endpoints, it would mark a
great advance in our ability to treat this traditionally
challenging group of patients."

Heart failure is a condition marked by the inability of the
heart muscles to pump enough oxygen and nutrients in the blood
to the body?s tissues. Also known as congestive heart failure,
its many causes include infections of the heart, coronary
artery disease, high blood pressure, previous heart attack and
valve problems.

An estimated 4.7 million Americans suffer from the
condition, with 400,000 new cases reported each year, and,
according to the researchers, it is the only cardiovascular
disease that is rising in incidence. Once diagnosed with heart
failure, about 50 percent of patients die within five
years.

Heart failure often leaves patients exhausted and
breathless, and the normal activities of these patients can be
severely restricted. Although there is no cure for the
disorder, a variety of drugs are often used to improve the
strength of the heartbeat (digoxin), to relax blood vessels
(ACE inhibitors), or to remove the excess buildup of fluid in
the lungs (diuretics).

While earlier heart failure studies were selective in the
types of patients who were enrolled, the new Duke-led study is
open to a large segment of the heart failure population,
according to Duke cardiologist David Whellan, M.D., who along
with O'Connor, Duke's William Kraus, M.D., and Kerry Lee,
Ph.D., Steve Keteyian, Ph.D., Henry Ford Health System,
Detroit, and Iliana Pina, M.D., University Hospital of
Cleveland, designed and will run the trial.

"The criteria for inclusion in the study are very broad,"
Whellan said, adding that potential candidates should consult
their health care provider or check the trial's Web site,
http://www.hfaction.org.

After medical histories and examinations, participants are
randomized to either an intensive exercise training or usual
care. Participants in the training arm will be given a
personalized exercise program. For the first three months,
patients will exercise three times weekly at the participating
institution, using either a treadmill or stationary bicycle.
After this initial period, patients will continue their
customized exercise regimen at home for up to three years. The
trial will supply the exercise equipment that patients will use
at home.

Additionally, members of the research team will maintain
frequent telephone contact with participants at home, both to
monitor their health and to ensure that they are continuing to
exercise.

The results of these studies will be compared to a group of
control patients who will receive the latest standard of care
for heart failure, but without the structured exercise
program.

"If the study proves positive, we hope to be able to make a
good case why third parties, such as CMS (Center for Medicare
and Medicaid Services) or insurance companies, should reimburse
their patients for exercise therapy," Whellan said. "It is one
of those cases of investing up-front in order to reap the
benefits farther downstream."

"If exercise proves to be effective in improving mortality
for heart failure patients, the implications for the health
care system and all patients with damaged hearts are enormous,"
O'Connor said.

O'Connor argues that exercise programs are already
well-established across the country for some patients. So, he
continues, if exercise is proven effective in lengthening the
life of heart failure patients, the infrastructure is already
in place to effectively treat this new group of heart
patients.

While mortality and hospitalization rates are the primary
measures in the trial, the researchers also hope to learn more
about any medical complications caused by exercise. The
researchers will also be able to determine those types of
patients who would benefit the most from exercise, and identify
those for whom exercise might be risky. They will also conduct
economic and quality of life analyses.

The trial has been dubbed HF-ACTION: Heart Failure -- A
Controlled Trial Investigating Outcomes of Exercise
TraiNing.

Other members of the Duke team include Robert Califf, M.D.,
James Blumenthal, Ph.D., Stuart Russell, M.D., Kevin Schulman,
M.D., Kevin Weinfurt, Ph.D., Shelby Reed, Ph.D., Dan Mark,
M.D., and Brian Duscha.