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Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Summary
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.
Key Details
Gender
All
Age Range
Any - 44 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-03-08
Completion Date
2026-03-07
Last Updated
2025-01-20
Healthy Volunteers
No
Conditions
Interventions
Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)
From the blood samples taken, 2 mL of plasma separated from blood will be stored in EDTA frozen at -80°C. This material will later be processed by NGS run using of CareDX kits. The result will be provided by dedicated software as percentage of donor DNA in relation to recipient DNA.
Locations (1)
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy