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NCT Number: NCT05824364

Exercise aNd hEArt Transplant

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

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Key information

Conditions

Heart Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • unable to sign informed consent

Treatment and study plan

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.

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)

Primary outcomes

  1. Cardiovascular events

    Time frame: 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 outcomes

  1. Vo2 peak

    Time frame: 6-months

    cardiometabolic equivalents (Vo2 peak)

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

    Time frame: 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.

  3. EuroQol 5-Dimension (EQ-5D-5L)

    Time frame: 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.

  4. Short Form 36 (SF36)

    Time frame: 6-months

    The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6-months

    The HADS is a 14-item generic questionnaire measuring symptoms of anxiety and depression within the last week.

Study contacts

Contact information is provided by the study sponsor or research team.

Marzia Bedoni, PhD

CONTACT

[email protected]

00390240308874

Nuccia Morici, MD

CONTACT

[email protected]

00390240308122

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Acronym: ENEA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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