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UrduThe study, which is testing a novel rehabilitation program designed for older patients hospitalized with acute heart failure, is funded by a five-year, $30 million grant, awarded to Wake Forest University School of Medicine in 2022 by the National Institute on Aging, part of the National Institutes of Health.
REHAB-HFpEF is a Phase III study, led by Dalane Kitzman, M.D., professor of cardiovascular medicine at Wake Forest University School of Medicine, and is among the first clinical trials to grow across a larger Advocate Health footprint since Advocate Aurora Health and Atrium Health combined in late 2022.
A team of scientists from the medical schools at Wake Forest University, Duke University and Thomas Jefferson University are examining whether a novel physical rehabilitation intervention will reduce rehospitalizations and mortality in patients hospitalized for heart failure with preserved ejection fraction (HFpEF).
Ejection fraction refers to the contraction ability of the heart. HFpEF is the most common form of heart failure in older adults. These frail patients have poor outcomes, and there are few proven treatments available.
“Expanding this research study to now include Advocate Christ Medical Center will enable us to enroll more patients, across a much larger footprint, and will help us better target patients who are among the most vulnerable and underserved populations,” Kitzman said. “The results of this study have the potential to change clinical practice, guidelines and policy across the country and improve the health of this high-risk population and our communities.”
The current Phase III study is enrolling 880 patients at 20 sites across the country, including Atrium Health Wake Forest Baptist Medical Center, in Winston-Salem (with Atrium Health Wake Forest Baptist High Point Medical Center as a satellite site) and Atrium Health Sanger Heart & Vascular Institute, in Charlotte (with Atrium Health’s Concord and Pineville medical centers as satellite sites).
“These sites are among the top enrolling sites in the study and the addition of Advocate Christ in the Chicago area will make this study even stronger,” Kitzman said.
Findings of a previous Phase II study with 349 patients, published in 2021 in the New England Journal of Medicine, showed that a different approach to rehabilitation significantly improved physical function. The novel method tailors rehabilitation treatment to each individual patient and begins while the patient is still recovering in the hospital, which is not standard care for these older patients with heart failure. The current Phase III study is investigating whether this intervention also reduces the likelihood of repeat hospitalizations and death in a larger group of patients.
“This clinical trial is an excellent example of how Advocate Health is utilizing its size and resources to improve cardiovascular care in a way that will benefit not only our own communities but also people across the entire country,” said Nikhil Narang, M.D., a cardiologist and advanced heart failure specialist who will serve as Advocate Christ’s principal investigator for the study.
As coordinating center for the study, the Wake Forest University School of Medicine team includes cardiovascular medicine, geriatrics, neurology, physical therapy and public health sciences.
“I am grateful for the incredible support of the principal investigators at our sites, and their teams, who are enthusiastic about participating in this clinical trial and the opportunities we have to potentially change the way we care for future patients.” Kitzman said.
