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Clinical Trials in Italy / NCT06774794
Recruiting Observational

Precision Medicine in the Management of Heart Transplant Recipients

NCT06774794 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-09-04
Last updated
2025-01-14

Condition(s) studied

Heart Transplantation

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Histological diagnosis of rejection leading to a change in immunosuppressive therapy according to clinical practice. — 5 years
    Histological diagnosis

Trial sites (1)

FacilityCityRegionStatus
Luciano Bologna Italy Recruiting

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Other trials for the same condition

Non-ischemic Preservation of the Donor Heart in Heart Transplantation Active, not recruiting
Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients Starting soon
Electronic Register on Advanced Heart Failure and Transplantation di Cuore Recruiting
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774794 on ClinicalTrials.gov ↗ ← All trials in Italy