Trifecta-Heart Study
Calibrating circulating donor-derived cell-free DNA against molecular biopsy assessments.
Investigators: Philip F Halloran, and the Trifecta-Heart Study Group (ClinicalTrials.gov NCT04707872)
Current methods for detecting rejection in heart transplant patients, particularly through histological assessment of endomyocardial biopsies, have notable limitations. To overcome these challenges, the Alberta Transplant Applied Genomics Centre has developed the Molecular Microscope® Diagnostic System (MMDx)—a definitive molecular assessment tool for evaluating rejection and injury in heart biopsies based on gene expression.
We are proud to introduce a new screening test that monitors donor-derived cell-free DNA (dd-cfDNA) in blood, specifically the Natera, Inc. dd-cfDNA Prospera™ test. This study aims to calibrate dd-cfDNA levels detected at the time of indication or protocol biopsies against MMDx measurements for various stages of rejection, including T-cell mediated rejection (TCMR), antibody-mediated rejection (ABMR) and its stages, as well as acute (early) and chronic (late) injury. We also want to determine whether resolution of dd-cfDNA levels after treatment can monitor response to therapy and avoid follow-up biopsies.
Our research will compare blood dd-cfDNA measurements taken at the time of biopsies with MMDx results, while also assessing HLA antibodies in blood samples. This study is an extension of the INTERHEART project (ClinicalTrials.gov ID: NCT02670408) and is currently being conducted at nine centers across the US, Canada, and Europe.
For more details, please click here: ClinicalTrials.gov NCT04707872
Trifecta-Heart Study Publications:
- Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS, Demko Z, Olymbios M, et al. Comparing Plasma Donor-derived Cell-free DNA to Gene Expression in Endomyocardial Biopsies in the Trifecta-Heart Study. Transplantation. 2024;108(9):1931-42.