ENEA: Exercise aNd hEArt Transplant

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05824364

Collaborator

(none)

Enrollment

Location

Arms

19.4

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart Transplant	Other: telerehabilitation Other: rehabilomic	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise aNd hEArt Transplant

Anticipated Study Start Date :

May 20, 2023

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Case two-four weeks of on-site cardiac rehabilitation (CR) followed by 12 weeks of telerehabilitation	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. 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)
Active Comparator: Control 4 weeks of on-site standard CR	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)

Arm

Intervention/Treatment

Experimental: Case

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

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.

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)

Active Comparator: Control

4 weeks of on-site standard CR

Other: rehabilomic

Outcome Measures

Primary Outcome Measures

Cardiovascular events [6-months]
Incidence of acute rejection, Rate of hospitalization for heart failure, Incidence of stroke, Incidence of myocardial infarction and incidence of all-cause mortality

Secondary Outcome Measures

Vo2 peak [6-months]
cardiometabolic equivalents (Vo2 peak)
extracellular vesicles (EVs) analysis with Surface Plasmon Resonance imaging (SPRi) [up to 4 weeks]
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.
EuroQol 5-Dimension (EQ-5D-5L) [6-months]
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.
Short Form 36 (SF36) [6-months]
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.
Hospital Anxiety and Depression Scale (HADS) [6-months]
The HADS is a 14-item generic questionnaire measuring symptoms of anxiety and depression within the last week.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

unable to sign informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Fondazione Don Gnocchi, Milan	Milan		Italy	20148

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

Principal Investigator: Nuccia Morici, MD, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nuccia Morici, Head of Cardiac Rehabilitation Department, Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT05824364

Other Study ID Numbers:

ENEA

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nuccia Morici, Head of Cardiac Rehabilitation Department, Fondazione Don Carlo Gnocchi Onlus

cardiac rehabilitation

telerehabilitation

rehabilomics

Study Results

No Results Posted as of Apr 21, 2023