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Exercise aNd hEArt Transplant — ENEA  

Heart Transplant Clinical Trial

Official title:
Exercise aNd hEArt Transplant

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05824364
Study type Interventional
Source Fondazione Don Carlo Gnocchi Onlus
Contact Nuccia Morici, MD
Phone 00390240308122
Email nmorici@dongnocchi.it
Status Recruiting
Phase N/A
Start date May 20, 2023
Completion date December 31, 2024
View Details
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