Condition: Congenital Heart Disease (CHD) · Heart Transplant Patients · Adult Congenital Heart Disease · Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.
This description comes directly from the study's public registry record.
Luca Ragni, MD · 0512149024 · luca.ragni@aosp.bo.it
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| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06784440