Cardiologists at Wake Forest University Baptist Medical Center are helping to lead a large international study involving 83 other sites that will test 3,000 patients in an effort to determine whether exercise really is good for heart failure patients.
Though doctors have promoted the value of exercise for a variety of disorders for years, “exercise training has not been definitively established as safe in the group of patients who primarily have heart failure,” said Dalane W. Kitzman M.D., a cardiologist who is principal investigator at Wake Forest Baptist, and colleagues, writing in the American Heart Journal.
“Controlled clinical trials have shown that exercise training improves physiological measurements” such as the distance that patients can walk in six minutes, they said after analyzing 14 trials. “None of these trials enrolled a sufficient number of patients to properly evaluate the impact of exercise training on death and hospitalization.”
The new trial, called Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) “is the largest randomized clinical trial of exercise training ever performed,” Kitzman said. “The trial represents a critical step in establishing exercise as a therapy for patients with left ventricular dysfunction” (reduced heart contractions).
He added, “The patient population enrolled in this trial will be a broad representation of heart failure patients, including large numbers of women, minorities and people from low socio-economic status.”
“The HF-ACTION trial has been designed so that if the intervention is beneficial, the treatment can be translated rapidly into general practice,” Kitzman said. In fact, the study leaders have met with Centers for Medicare & Medicaid Services, the office that assesses whether there is enough proof that a treatment is effective and safe in order to be paid for by Medicare, to help ensure that exercise programs would qualify for Medicare if the study is positive.