Exercise aNd hEArt Transplant

NCT05824364 | Recruiting

• 1 other identifier: ENEA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Transplant

Keywords

cardiac rehabilitation; telerehabilitation; rehabilomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Vo2 peak

  6-months

• extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi)

  up to 4 weeks

• EuroQol 5-Dimension (EQ-5D-5L)

  6-months

• Short Form 36 (SF36)

  6-months

• Hospital Anxiety and Depression Scale (HADS)

  6-months

Study Arms (2)

Case

EXPERIMENTAL

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

Other: telerehabilitation; Other: rehabilomic

Control

ACTIVE COMPARATOR

4 weeks of on-site standard CR

Other: rehabilomic

Interventions

telerehabilitation 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.

Case

rehabilomic 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)

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to sign informed consent

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Gnocchi, Milan

Milan, Milan, 20148, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 38114046 DERIVED

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nuccia Morici, MD

  IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuccia Morici, MD

CONTACT

00390240308122; nmorici@dongnocchi.it

Marzia Bedoni, PhD

CONTACT

00390240308874; mbedoni@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Rehabilitation Department

Model Details: parallel and cross over designs will be adopted according to the specific purposes of that given clinical study

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: April 21, 2023
• Study Start: May 20, 2023
• Primary Completion: September 30, 2025
• Study Completion: November 28, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)