Exercise aNd hEArt Transplant

NCT ID: NCT05824364

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2025-11-28

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.

Conditions

Heart Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Case

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

Group Type: EXPERIMENTAL

telerehabilitation

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Control

4 weeks of on-site standard CR

Group Type: ACTIVE_COMPARATOR

rehabilomic

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: OTHER

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• unable to sign informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Nuccia Morici

Head of Cardiac Rehabilitation Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuccia Morici, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

Locations

IRCCS Fondazione Don Gnocchi, Milan

Milan, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nuccia Morici, MD

Role: CONTACT

nmorici@dongnocchi.it

00390240308122

Marzia Bedoni, PhD

Role: CONTACT

mbedoni@dongnocchi.it

00390240308874

Facility Contacts

Nuccia Morici, MD

Role: primary

nmorici@dongnocchi.it

00390240308122

Marzia Bedoni, PhD

Role: backup

mbedoni@dongnocchi.it

00390240308874

References

Pedersini P, Picciolini S, Di Salvo F, Toccafondi A, Novembre G, Gualerzi A, Cusmano I, Garascia A, Tavanelli M, Verde A, Masciocco G, Ricci C, Mannini A, Bedoni M, Morici N. The Exercise aNd hEArt transplant (ENEA) trial - a registry-based randomized controlled trial evaluating the safety and efficacy of cardiac telerehabilitation after heart transplant. Contemp Clin Trials. 2024 Jan;136:107415. doi: 10.1016/j.cct.2023.107415. Epub 2023 Dec 17.

Reference Type: DERIVED

PMID: 38114046 (View on PubMed)

Other Identifiers

ENEA

Identifier Type: -

Identifier Source: org_study_id