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Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation

RecruitingNAAges any - 44 YearsAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06784440 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patients with congenital heart disease undergoing cardiac transplantation at our center or other centers, followed in follow-up at our center (Unit of Pediatric Cardiology and Developmental Age, IRCCS Azienda Ospedaliero-Universitaria di Bologna) * Pediatric patients undergoing cardiac transplantation at our center or other centers but followed in follow-up at our center * Obtaining informed consent from the adult patient or parent/guardian in case of minor Exclusion Criteria: * Failure to obtain informed consent from the adult patient or parent/guardian in case of minor
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What it tests

  • Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)
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Where

1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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