Exercise aNd hEArt Transplant (ENEA)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Heart Transplant

Treatments: Other: telerehabilitation; Other: rehabilomic

Study type: Interventional

Funder types: Other

Identifiers

NCT05824364

ENEA

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All the patients admitted in the on-site CR after HTx

Exclusion criteria

• unable to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Case

Experimental group

Description:

two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation

Treatment:

Other: rehabilomic

Other: telerehabilitation

Control

Active Comparator group

Description:

4 weeks of on-site standard CR

Treatment:

Other: rehabilomic