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 Website, 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 -- AControlled 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.