Clinical Trials Logo
  1. Home
  2. Heart Transplant
  3. NCT05824364

Exercise aNd hEArt Transplant — ENEA  

Heart Transplant Clinical Trial

Official title:
Exercise aNd hEArt Transplant

Clinical Trial 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05824364
Study type Interventional
Source Fondazione Don Carlo Gnocchi Onlus
Contact Nuccia Morici, MD
Phone 00390240308122
Email nmorici@dongnocchi.it
Status Recruiting
Phase N/A
Start date May 20, 2023
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Active, not recruiting NCT05096299 - OCS Heart EXPAND + CAP Continued Follow-Up
Completed NCT02323321 - International EXPAND Heart Pivotal Trial N/A
Recruiting NCT05933083 - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation N/A
Completed NCT03150095 - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates N/A
Active, not recruiting NCT02554578 - Impact of mHealth in Heart Transplant Management N/A
Terminated NCT03346278 - Text Message Intervention to Improve Cardiac Rehab Participation N/A
Active, not recruiting NCT05741723 - OCS DCD Heart + CAP Continued Follow-Up
Completed NCT03831048 - Donors After Circulatory Death Heart Trial N/A
Completed NCT04615182 - Donor After Circulatory Death Heart CAP Trial N/A
Completed NCT02597543 - Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction Phase 4
Not yet recruiting NCT05025774 - Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
Enrolling by invitation NCT05390411 - Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial N/A
Recruiting NCT04770012 - AERIAL Trial: Antiplatelet Therapy in Heart Transplantation Phase 3
Terminated NCT01769443 - Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation Phase 2
Completed NCT00466804 - Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients N/A
Not yet recruiting NCT05459181 - HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC) N/A
Terminated NCT01485757 - Prospective L-arginine Study Phase 1
Active, not recruiting NCT01186250 - Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation Phase 2
Completed NCT00812786 - Pharmacokinetics of Immunosuppressive Drugs in Heart Transplant Patients Phase 4