The goal of this clinical trial is to demonstrate that a multiparametric approach, based on the integration of biomolecular, histological, imaging, and clinical information, along with the use of machine learning methods, can identify among heart transplant patients those at higher risk of rejection, infectious events, and chronic graft dysfunction.
Patients have been and will be treated according to clinical practice, in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product used in concomitant therapies, if administered according to clinical practice. The diagnostic-therapeutic pathway of the patients will not be in any way influenced by the results of tissue tests performed for the purposes of the study
Age ≥ 18 years
Have received an orthotopic heart transplant
Clinical indication for performing a myocardial biopsy (either as part of standard monitoring or for suspected rejection)
Obtaining informed consent
Severe complications in the post-operative phase that may limit the patient's short-term survival.
All adult patients undergoing orthotopic heart transplantation, attending the SSD Heart Failure and Transplants unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna, will be enrolled from 01/02/2023 to 31/12/2027. Each patient will be followed according to standard clinical care practices; the minimum follow-up for each patient will be 6 months.
Cohort
Prospective
Not listed
Histological diagnosis of rejection leading to a change in immunosuppressive therapy according to clinical practice.
Histological diagnosis
Symptomatic infection requiring treatment with antimicrobial drugs
Infection from SARS-CoV-2 is excluded from this endpoint and will be analyzed separately
Development of myocardial fibrosis diagnosed on cardiac MRI
myocardial fibrosis diagnosis
Hospitalization for any cause.
Hospitalization
Mortality from any cause.
Mortality
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