Key result
Cardiac telerehabilitation awaits safety and efficacy results in the ongoing ENEA heart transplant trial.
Why the study?
To explore the safety and efficacy of cardiac telerehabilitation after heart transplant and identify biomarkers of rehabilitation outcomes.
Does a 12-week telerehabilitation program following on-site cardiac rehabilitation improve clinical and functional outcomes in heart transplant recipients?
RCT (n=40)
1:1
No
Does a 12-week telerehabilitation program following on-site cardiac rehabilitation improve clinical and functional outcomes in heart transplant recipients?
The ENEA trial will evaluate whether a 12-week telerehabilitation program improves functional and clinical outcomes in heart transplant recipients compared to standard homecare.
May support phenotype-tailored telerehabilitation post-HTx; leaves open safety and efficacy pending randomized confirmation.
BACKGROUND: Heart transplant (HTx) is gold-standard therapy for patients with end-stage heart failure. Cardiac rehabilitation (CR) is a multidisciplinary intervention shown to improve cardiovascular prognosis and quality of life. The aim in this randomized controlled trial is to explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, biomarkers of rehabilitation outcomes will be identified, as data that will enable treatment to be tailored to patient phenotype. METHODS: Patients after HTx will be recruited at IRCCS S. Maria Nascente - Fondazione Don Gnocchi, Milan, Italy (n = 40). Consenting participants will be randomly allocated to either of two groups (1:1): an intervention group who will receive on-site CR followed by 12 weeks of telerehabilitation, or a control group who will receive on-site CR followed by standard homecare and exercise programme. Recruitment began on 20th May 2023 and is expected to continue until 20th May 2025. Socio-demographic characteristics, lifestyle, health status, cardiovascular events, cognitive function, anxiety and depression symptoms, and quality of life will be assessed, as well as exercise capacity and muscular endurance. Participants will be evaluated before the intervention, post-CR and after 6 months. In addition, analysis of circulating extracellular vesicles using Surface Plasmon Resonance imaging (SPRi), based on a rehabilomic approach, will be applied to both groups pre- and post-CR. CONCLUSION: This study will explore the safety and efficacy of cardiac telerehabilitation after HTx. In addition, a rehabilomic approach will be used to investigate biomolecular phenotypization in HTx patients. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05824364.
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Pedersini et al. (2023) conducted an RCT in Heart transplant (n=40). Cardiac telerehabilitation vs. Standard homecare and exercise programme was evaluated on Safety and efficacy (including cardiovascular events, exercise capacity, and quality of life). The ENEA trial is an ongoing randomized controlled trial designed to evaluate the safety and efficacy of cardiac telerehabilitation in 40 heart transplant patients, with no results reported yet.
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