Exercise aNd hEArt Transplant

Heart Transplant Clinical Trial

— ENEA  

Official title:

Exercise aNd hEArt Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824364
• Other study ID #: ENEA
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Nuccia Morici, MD
• Phone: 00390240308122
• Email: nmorici[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• unable to sign informed consent

Related Conditions & MeSH terms

• Heart Transplant

Intervention

Other:
• telerehabilitation
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.
• rehabilomic
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)

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Gnocchi, Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vo2 peak	cardiometabolic equivalents (Vo2 peak)	6-months
Secondary	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
Secondary	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
Secondary	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
Secondary	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