Swedish National Study on Donor-Derived Cell-Free DNA to Monitor Rejection After Heart Transplantation

What this Trial Is About

Researchers are conducting an observational, multicenter cohort study called the SweD-HTx study, involving adult heart transplant recipients from three Swedish university hospitals. The study aims to develop a nationwide protocol for monitoring transplant rejection using donor-derived cell-free DNA dd-cfDNA and to better understand rejection mechanisms and immune activation. This study focuses on adults who have undergone orthotopic heart transplantation, with exclusion of those who are pregnant or have had multiple organ or stem cell transplants. Participants receive routine post-transplant care including endomyocardial biopsies at scheduled intervals. Blood samples are collected alongside these biopsies for dd-cfDNA and donor-specific antibody DSA analysis, using next-generation sequencing and standardized laboratory procedures. The study will analyze the relationship between dd-cfDNA levels and biopsy-confirmed rejection, following international histopathological criteria. The collection of clinical and demographic data from electronic medical records supports comprehensive analysis. Participants are monitored over several years with blood sampling coordinated with routine biopsies during the first two years post-transplant and annual data collection up to five years. Outcomes include the correlation between dd-cfDNA fraction levels and biopsy-proven rejection, longitudinal changes in dd-cfDNA and DSA, and their association. Safety and standard care continue throughout, with data securely managed and analyzed to improve rejection monitoring methods in heart transplantation.

A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation