Heart Failure and the HF-ACTION Trial

HF-ACTION stands for Heart Failure: A Controlled Trial Investigating Outcomes of Exercise TraiNing

Introduction
Many of the advances and improvements that we see in medicine today were found to be effective through clinical research trials. In each trial there is a well thought-out plan designed to find new, safe, and better ways to treat diseases and prevent health problems.

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What is HF-ACTION about?
HF-ACTION was designed to determine whether a tailored exercise program can help heart failure patients live longer. The trial was sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the Federal Government’s National Institutes of Health (NIH) and was conducted at approximately 50 different sites in the U.S. and Canada.

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Why is HF-ACTION important?
While many trials conducted over the past decade have shown that exercise can have a positive effect on symptoms suffered by heart failure patients, the 6-year, 2,331-patient randomized trial, conducted at 82 U.S., Canadian, and French sites, was the first such large-scale prospective trial designed to determine whether exercise can reduce mortality for patients with heart failure.

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

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What is heart failure?
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, and previous heart attack and valve problems.

An estimated 4.8 million Americans suffer from the condition, with 550,000 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 will 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 and angiotensin receptor blockers), or to remove the excess buildup of fluid in the lungs (diuretics).

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How is HF-ACTION different from previous heart failure trials?
While earlier heart failure studies were very selective in the types of patients who were enrolled, the HF-ACTION Trial was open to a large segment of the heart failure population. The criteria for inclusion in the study were very broad. The majority of patients with a weak heart were candidates for participation in the study. The exercise regimen was tailored to each patient’s particular medical condition and physical ability.

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What will happen during the HF-ACTION trial?
After medical histories and examinations, participants were randomized to either intensive exercise training or usual care. Participants in the exercise training arm were given a personalized exercise program. For the first three months, participants exercised three times weekly at the participating institution, using either a treadmill or stationary bicycle. After this initial period, participants continued their customized exercise regimen at home for up to three years. The trial supplied the exercise equipment that patients used at home.

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

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

While mortality and hospitalization rates were the primary outcome measures in the trial, researchers learned more about any medical complications caused by exercise. The researchers also wanted to 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 also conducted genetic, economic, and quality of life analyses.

The trial, which was funded by the NIH’s National Heart, Lung, and Blood Institute, has been dubbed HF-ACTION: Heart Failure—A Controlled Trial Investigating Outcomes of Exercise TraiNing.

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