Health TrialsbyHealthPanel

Exercise aNd hEArt Transplant

ConditionHeart Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

unable to sign informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • telerehabilitation

    Other intervention

    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 intervention

    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)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CaseExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

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

Time frame
6-months

Secondary outcomes

1

Vo2 peak

cardiometabolic equivalents (Vo2 peak)

Time frame
6-months
2

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.

Time frame
up to 4 weeks
3

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.

Time frame
6-months
4

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.

Time frame
6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Source ClinicalTrials.gov
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