Precision Medicine in the Management of Heart Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Medicine in the Management of the Heart Transplant Patient: Advanced Molecular and Imaging Approaches
Overview
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
Detailed description
The main focus of the study, and the primary outcome measure, is the diagnosis of rejection based on the histopathological examination of myocardial biopsies. At the time of each biopsy procedure, or within the 5 days immediately preceding, enrolled patients will undergo specific non-invasive investigations, along with baseline clinical and laboratory evaluations.
Additional analyses will be performed on myocardial tissue samples obtained during biopsies conducted for clinical practice, including the analysis of the intramyocardial gene expression profile (nanostring and microarray), to identify molecular profiles specific to cellular or antibody-mediated rejection.
The results of these investigations will be correlated with the findings from histopathological and molecular analyses of the biopsies using artificial intelligence methods, in order to develop a non-invasive investigation algorithm that can predict the risk of rejection.
Similarly, these diagnostic investigations will be longitudinally related to the incidence of infection events, as defined above, and to the development of myocardial fibrosis diagnosed by cardiac magnetic resonance imaging.
In a subsequent phase, biopsies will be reclassified through the examination of histopathological morphology using machine learning techniques. The result of the re-evaluation of the histological samples will be correlated with the diagnosis based on the intramyocardial gene expression and the predictiveness of the previously developed algorithm.
Primary outcome measures
- Histological diagnosis of rejection leading to a change in immunosuppressive therapy according to clinical practice. [Time frame: 5 years]
Secondary outcome measures (4)
- Symptomatic infection requiring treatment with antimicrobial drugs [Time frame: 5 years]
- Development of myocardial fibrosis diagnosed on cardiac MRI [Time frame: 5 years]
- Hospitalization for any cause. [Time frame: 5 years]
- Mortality from any cause. [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Severe complications in the post-operative phase that may limit the patient's short-term survival.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Luciano — Bologna
Identifiers
NCT: NCT06774794 · Precision-HT · RC-2022-2773280