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

Launched by MEDICAL UNIVERSITY OF VIENNA · May 13, 2025

Keywords

ClinConnect Summary

The ZeroHeart Biopsy study is looking into whether testing small samples of heart tissue from organ donors can help predict how well a transplanted heart will function in patients. The researchers want to find out if they can detect early signs of injury in the donor heart at the time it is removed, which might indicate how well the heart will work after the transplant. They will compare results from different types of donors to see if these early signals can help forecast issues like rejection or poor function of the transplanted heart in the future.

To participate in this study, heart donors must meet specific criteria, including being from standard or expanded donor categories, which means they are either healthy or have some risks but can still provide viable organs. The study requires taking two tiny samples of heart tissue during the organ removal process, but there are no extra procedures for the transplant recipients beyond what is already standard care. This research aims to improve heart transplant outcomes and make the process safer for patients receiving donor hearts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All hearts from standard and expanded criteria donors as well as donor hearts from Donation after circulatory death (DCD) undergoing a heart biopsy at pre-implantation (at procurement) will be included. Consent will be obtained from the recipient at the time of transplant listing.
• Exclusion Criteria:
• • Hearts will be excluded from the study if the participating clinician decides to discard the organ before transplantation or the recipient declines that the biopsy will be performed at the organ procurement.