Heart Transplant Patients Study Using Cardiac Imaging and Biomarkers to Detect Antibody-Mediated Rejection

What this Trial Is About

Researchers are studying heart transplant recipients who are clinically stable but have donor specific antibodies DSA detected during routine monitoring. This observational study aims to assess inflammation and fibrosis in the heart using cardiac magnetic resonance imaging CMR. The main focus is to understand how common fibrosis, swelling, and changes in T1 mapping values are among patients with DSA and the overall prevalence of DSA in the group studied. Participants will be enrolled when they have a DSA test as part of their regular heart transplant follow-up, which includes yearly screening for anti-HLA antibodies. Blood samples will be collected to measure donor-derived cell-free DNA dd-cfDNA and regulatory T cell T-reg populations. Treatments and procedures will follow standard medical guidelines and are not influenced by study results. Physicians caring for participants will not have access to study assay results to ensure unbiased clinical decisions. During the study, clinical information, medical history, and standard lab tests will be gathered at the start. The study will track the prevalence of heart tissue changes related to DSA over five years, as well as differences in biomarkers and imaging findings between patients with and without DSA. Researchers will also observe changes after antibody-mediated rejection treatment and monitor major adverse cardiac events MACE. The total participation time extends up to five years with periodic assessments.

CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation