Heart Transplant
Conditions
Keywords
cardiac rehabilitation, telerehabilitation, rehabilomics
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.
Interventions
OTHERtelerehabilitation
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.
OTHERrehabilomic
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)
Sponsors
Fondazione Don Carlo Gnocchi ETS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
parallel and cross over designs will be adopted according to the specific purposes of that given clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All the patients admitted in the on-site CR after HTx
Exclusion criteria
* unable to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Vo2 peak | 6-months | cardiometabolic equivalents (Vo2 peak) |
| 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. |
| 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. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORNuccia Morici, MD
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
Outcome results
None listed