Exercise aNd hEArt Transplant

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Exercise aNd hEArt Transplant

Conditions
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Heart Transplant

Intervention / Treatment
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* Other: telerehabilitation
* Other: rehabilomic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients admitted in the on-site CR after HTx Exclusion Criteria: unable to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel and cross over designs will be adopted according to the specific purposes of that given clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case<br>two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation | Other: telerehabilitation<br>* 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.<br>Other: rehabilomic<br>* 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)<br>|
| Active Comparator: Control<br>4 weeks of on-site standard CR | Other: rehabilomic<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, telerehabilitation, rehabilomics