The Exercise aNd hEArt Transplant (ENEA) Trial: A Randomized Controlled Trial of Cardiac Rehabilitation After Heart Transplantation

Background: Heart transplantation (HTx) remains the gold-standard therapy for patients with end-stage heart failure. Cardiac rehabilitation (CR) is a multidisciplinary intervention that improves cardiovascular prognosis and quality of life. The aim of this randomized controlled trial was to evaluate the impact of cardiac telerehabilitation on cardiovascular events after HTx. Methods: Forty patients who had undergone HTx were recruited at a single Italian institution and randomly allocated 1:1 to an experimental group (on-site CR followed by 12 weeks of telerehabilitation) or a control group (on-site CR followed by standard homecare and an exercise program). The primary outcome was a 6-month composite of major cardiovascular events, including acute allograft rejection, heart failure hospitalization, coronary allograft vasculopathy, stroke, and all-cause mortality. Secondary outcomes included return to work within 6 months, physical and functional activity levels and treatment adherence. Results: Forty patients were equally allocated to control and experimental groups, with well-balanced baseline demographic, clinical, and functional characteristics. At 6 months, the primary composite endpoint occurred in 35% of patients in both groups, with no significant between-group differences. Return to work was observed in 72.2% of the controls and 64.3% of intervention patients. Physical activity levels were comparable between groups, with most patients classified as sufficiently active. Adherence to the cardiac telerehabilitation program was complete in only 50% of the patients. Conclusions: In this randomized trial on HTx patients, a hybrid telerehabilitation program was as safe as standard care regarding major cardiovascular events at 6 months. The low adherence observed suggests that future digital interventions must focus on enhancing patient engagement.