Image

Exercise aNd hEArt Transplant

Exercise aNd hEArt Transplant

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to sign informed consent

Study details
    Heart Transplant

NCT05824364

Fondazione Don Carlo Gnocchi Onlus

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.