What the trial was testing
The REGROUP enrolled 1,150 patients with heart failure. The study was sponsored by VA Office of Research and Development and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
Researchers followed patients through treatment and into recovery, tracking the outcomes that mattered most for the disease being studied.
What the results showed
15.5% of open-harvest patients and 13.9% of endoscopic-harvest patients had major heart events—no significant difference.
The New England journal of medicine · 2019 · NCT01850082
These findings — that no meaningful difference in death, heart attack, or repeat procedures between the two harvesting methods — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 1,150 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with heart failure, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Both vein-harvesting techniques are widely used and FDA-cleared for bypass surgery. If you're having bypass, ask your surgeon which method they use and why. Endoscopic harvest may lower leg wound infections slightly, but overall heart outcomes appear similar.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open heart failure trials
The Sarcopenia Study
The goal of this cross-sectional study is to investigate the prevalence of sarcopenia in patients with Heart Failure. The main question it aims to answer is: Whether there is a difference in the prevalence of sarcopenia across the spectrum of HFpEF (Heart failure with preserved ejection fraction) and HFrEF (heart failure with reduced ejection fraction). This is an observational study. The participant population involves patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction. Healthy volunteers will be recruited as controls in addition to adults with asymptomatic Type 2 Diabetes. Participants will undergo the following: 1. Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA) 2. Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength) 3. Skeletal muscle energetics assessment (31p-Spectroscopy pre/post-exercise recovery) Researchers will compare Heart failure groups with healthy controls and adults with asymptomatic type 2 Diabetes to see if there are significant differences in the strength, mass and quality of skeletal muscle.
PRIME HFrEF: Novel Exercise for Older Patients With Heart Failure With Reduced Ejection Fraction
This study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled PRIME: Peripheral Remodeling via Intermittent Muscular Exercise) results in better health outcomes than the traditional exercise training program (called COMBO) that is used in individuals with heart failure with reduced ejection fraction (HFrEF). Participants will be randomized (like the flip of a coin) to either PRIME (investigational) or the traditional exercise program (standard of care).