What this Trial Is About

Researchers are evaluating a new, noninvasive method to detect acute rejection in patients who have undergone orthotopic heart transplantation. This study focuses on patients of all ages, including both pediatric and adult individuals with congenital heart disease. The goal is to assess whether measuring plasma levels of circulating donor-derived cell free DNA (Dd-cfDNA) in the recipient's blood can predict acute myocardial rejection as accurately as the current gold standard, which is immunohistochemical analysis of endomyocardial biopsy samples. About 20 patients will be enrolled and followed at a single center. Each time a patient undergoes an endomyocardial biopsy, a blood sample will be taken simultaneously to measure Dd-cfDNA levels. For those with biopsy-confirmed acute rejection, an additional blood sample will be collected approximately three months after treatment during a clinical follow-up. The blood samples will be processed using specialized kits and next-generation sequencing to determine the percentage of donor DNA relative to recipient DNA. Participants will have their baseline information, imaging, and laboratory data collected as part of routine follow-up. Researchers will compare the biopsy results with Dd-cfDNA levels to evaluate this new diagnostic method. The study includes monitoring plasma levels of Dd-cfDNA one day after biopsy to determine its potential as a marker of graft injury. The total number of participants is around 20, with ongoing follow-up according to clinical practice.

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