Study Comparing Blood Tests and Biopsy Tests for Detecting Heart Transplant Rejection Using DD-cfDNA, MMDx Microarray, and HLA Antibody Tests

What this Trial Is About

Researchers are investigating the relationship between donor-derived cell-free DNA DD-cfDNA levels, HLA antibodies in blood, and results from the Molecular Microscope Diagnostic System MMDx in heart transplant recipients. The study aims to improve accuracy in detecting rejection by comparing the new DD-cfDNA blood test Prospera with the MMDx microarray test and central HLA antibody measurements. This observational study builds on previous work and addresses the challenge of variability in traditional biopsy interpretations. Participants include heart transplant patients undergoing biopsies either for clinical reasons or as part of routine protocol monitoring, especially in high-risk cases. The study collects blood samples at the time of biopsies to measure DD-cfDNA and HLA antibodies, while biopsies are analyzed using the MMDx system. The study plans to include 300 additional biopsies and corresponding blood samples to calibrate the Prospera test against MMDx diagnoses of different types of rejection and tissue injury. During the study, participants will have biopsies and blood samples collected as part of their regular care. Researchers will analyze gene expression from biopsies and measure DD-cfDNA and HLA antibodies in blood samples. The primary outcomes involve calibrating the Prospera test for different rejection types and heart injury over 18 months. Secondary outcomes assess whether the blood test could replace biopsies. Safety and antibody status will also be monitored, with the study continuing through 2028.

Trifecta-Heart cfDNA-MMDx Study