The purpose of this study is to identify unique characteristics of pathological donor-specific antibodies (DSAs). Pathological DSAs cause injury to the transplanted heart (also known as graft injury), unlike DSAs that may have attained immunological accommodation (resistance) and are not causing graft injury. Participants in this study are heart transplant recipients and either have these antibodies or have been identified as healthy volunteers with no antibodies. As many as one third of heart transplant recipients develop antibodies directed against the donor heart. Studies have shown that the presence of these antibodies elevates the risk of graft loss, chronic rejection, and development of blockages in the vessels of the heart. However, scientists currently do not have effective tests that show which antibodies are harmful and causing graft injury, versus innocent bystanders. This study aims to use new techniques to identify the harmful antibodies so that appropriate treatments can be designed. Study procedures include medical record review, blood draw, and collection of tissue leftover from standard of care endomyocardial biopsies.
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What is the full name of this clinical trial?
Functional characterization of post heart transplant de novo donor specific antibodies