Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824364
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-01-16
Brief Title:
Exercise aNd hEArt Transplant
Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Exercise aNd hEArt Transplant
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENEA
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None