Pilot Study on Using Donor Heart Biopsies at Organ Removal to Predict Transplant Outcomes in Adult Heart Transplant Recipients

What this Trial Is About

This research aims to assess whether molecular analysis of donor heart biopsies taken at the time of organ removal can predict how well the transplanted heart will function and the risk of rejection in adult heart transplant recipients. It focuses on detecting early molecular injury caused by brain death or circulatory death and evaluating how these findings relate to short-, mid-, and long-term outcomes after transplantation. The study involves collecting two small biopsies from donor hearts at the time of organ removal one for routine pathology and one for detailed molecular analysis using microarray technology. These biopsies come from both standard and marginal donors, including those after brain death and circulatory death, and the molecular profiles are compared to see if early injury signals correspond to later transplant success or complications. Participants include donors whose hearts are transplanted, and recipients who provide consent at transplant listing. Follow-up biopsies are performed as part of usual care after transplantation, with no extra procedures required for the study. Researchers will monitor transplant outcomes up to 12 months, focusing on how well the heart functions based on molecular biopsy results taken at Time Zero.

ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study