Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
Recruiting now · Not applicable
Conditions studied: Congenital Heart Disease (CHD), Heart Transplant Patients, Adult Congenital Heart Disease, Pediatric Congenital Heart Disease
In brief
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 facts
- Study ID
- NCT06784440
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 20
- Starts
- 2023-03-08
- Expected to finish
- 2026-03-07
- Last updated by the study team
- 2025-01-20
Who can join
Age: any, up to 44. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Failure to obtain informed consent from the adult patient or parent/guardian in case of minor
Where it is running
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.