Exercise aNd hEArt Transplant
- Conditions
- Heart Transplant
- Interventions
- Other: telerehabilitationOther: rehabilomic
- Registration Number
- NCT05824364
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Brief Summary
Registry-based randomized clinical trial (RRCT) to assess the safety and efficacy of two different schemes of exercise training in patients who have recently undergone heart transplantation
- Detailed Description
40 patients who achieved Heart transplantation (HTx) will be randomized in a pilot study to 4 weeks of on-site standard CR (control arm) versus two-four weeks of on-site CR followed by 12 weeks of telerehabilitation (experimental arm). Both surrogate endpoints \[cardiometabolic equivalents (Vo2 peak)\] and clinical endpoint \[primary outcome defined as acute rejection, hospitalization for heart failure, stroke, myocardial infarction, all-cause mortality, at the longest follow-up available (minimum 6-month follow-up)\] will be evaluated.
The rehabilomic approach will be applied in order to identify specific patients' phenotype. To identify the potential variations of circulating molecules levels that could be indicators of the rehabilitation outcome and/or progression of the disease, the research team will focus on the analysis of extracellular vesicles (EVs) isolated from the serum of the 40 patients at admission (T0) and after cardiac rehabilitation (T1). In particular, researchers will detect and analyze the relative amount of serum EVs derived from platelets, endothelium, cardiomyocytes, and macrophages, as their levels are reported to be associated with the occurrence of heart failure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- All the patients admitted in the on-site CR after HTx
- unable to sign informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Case rehabilomic two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation Case telerehabilitation two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation Control rehabilomic 4 weeks of on-site standard CR
- Primary Outcome Measures
Name Time Method Cardiovascular events 6-months Incidence of acute rejection, Rate of hospitalization for heart failure, Incidence of stroke, Incidence of myocardial infarction and incidence of all-cause mortality
- Secondary Outcome Measures
Name Time Method extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi) up to 4 weeks EVs will be isolated from blood, characterized by standard procedures and injected on the SPRi biosensor for the differential quantification of multiple EV subfamilies. The expression of a secondary antigen will be evaluated on the surface of immobilized EVs.
Vo2 peak 6-months cardiometabolic equivalents (Vo2 peak)
EuroQol 5-Dimension (EQ-5D-5L) 6-months The EQ-5D-5L is a generic questionnaire measuring five domains of current health-related quality of life, where a higher index score indicates higher health-related quality of life.
Short Form 36 (SF36) 6-months The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
Hospital Anxiety and Depression Scale (HADS) 6-months The HADS is a 14-item generic questionnaire measuring symptoms of anxiety and depression within the last week.
Trial Locations
- Locations (1)
IRCCS Fondazione Don Gnocchi, Milan
🇮🇹Milan, Italy