Study of Noninvasive Blood Test for Detecting Heart Transplant Rejection in Children and Adults with Congenital Heart Disease

What this Trial Is About

Researchers are evaluating a new diagnostic method to detect acute myocardial rejection in patients undergoing orthotopic heart transplantation. This study includes both pediatric and adult patients with congenital heart disease. The goal is to see if measuring plasma levels of donor-derived cell free DNA Dd-cfDNA in the recipients blood can predict rejection as accurately as the current gold standard, which is immunohistochemical analysis of endomyocardial biopsy samples. In this drug-free study, about 20 patients will be enrolled and monitored at a single center. Whenever a patient has an endomyocardial biopsy for rejection surveillance or suspicion, a blood sample will be taken at the same time to analyze Dd-cfDNA levels. If acute rejection is confirmed by biopsy, the patient will have another Dd-cfDNA blood test approximately three months after treatment during their next follow-up visit. Blood samples will be processed using next-generation sequencing and specialized software to determine the percentage of donor DNA compared to recipient DNA. Participants will have routine clinical follow-up visits where their physical measurements, imaging, laboratory tests, biopsy results, and blood tests for donor DNA will be collected. The primary outcome is the measurement of circulating Dd-cfDNA levels in the blood, assessed on the day of biopsy. This study will provide important data on whether this less invasive blood test can effectively monitor heart transplant rejection. The study is expected to continue until March 2026.

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