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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Experimental | two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation |
|
| Control | Active Comparator | 4 weeks of on-site standard CR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telerehabilitation | Other | Telerehabilitation activites will be tested with the aim to provide 1) continuation of rehabilitative care, focused on physical training and patients'monitoring , and 2) information in the mid-term about study goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | Incidence of acute rejection, Rate of hospitalization for heart failure, Incidence of stroke, Incidence of myocardial infarction and incidence of all-cause mortality | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Vo2 peak | cardiometabolic equivalents (Vo2 peak) | 6-months |
| extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuccia Morici, MD | Contact | 00390240308122 | nmorici@dongnocchi.it | |
| Marzia Bedoni, PhD | Contact | 00390240308874 | mbedoni@dongnocchi.it |
| Name | Affiliation | Role |
|---|---|---|
| Nuccia Morici, MD | IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Gnocchi, Milan | Recruiting | Milan | Milan | 20148 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38114046 | Derived | Pedersini P, Picciolini S, Di Salvo F, Toccafondi A, Novembre G, Gualerzi A, Cusmano I, Garascia A, Tavanelli M, Verde A, Masciocco G, Ricci C, Mannini A, Bedoni M, Morici N. The Exercise aNd hEArt transplant (ENEA) trial - a registry-based randomized controlled trial evaluating the safety and efficacy of cardiac telerehabilitation after heart transplant. Contemp Clin Trials. 2024 Jan;136:107415. doi: 10.1016/j.cct.2023.107415. Epub 2023 Dec 17. |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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parallel and cross over designs will be adopted according to the specific purposes of that given clinical study
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| rehabilomic | Other | blood withdrawal (10 ml of blood, two tubes of 5 ml for serum isolation): at the hospital admission at the Cardiac Rehabilitation Unit of IRCCS Fondazione Don Gnocchi of Milan (T0) and after the rehabilitative treatment (T1) |
|
| up to 4 weeks |
| EuroQol 5-Dimension (EQ-5D-5L) | 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. | 6-months |
| Short Form 36 (SF36) | The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. | 6-months |
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a 14-item generic questionnaire measuring symptoms of anxiety and depression within the last week. | 6-months |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |