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

Recruitingn/aAges any - anyAllMedical University of Vienna
NCT06982404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal ("Time Zero") can help predict the future function and rejection risk of the transplanted heart in adult transplant recipients. The main questions it aims to answer are: * Can early molecular injury in the donor heart, caused by brain death or circulatory death, be detected at the time of organ removal? * Can these early molecular findings predict short-, mid-, and long-term transplant outcomes, such as graft function or rejection? Participants will: * Include heart donors whose hearts are being transplanted (both standard and marginal donors, including DBD and DCD cases) * Provide two small biopsies from the donor heart at the time of organ removal: one for routine pathology, one for microarray-based molecular analysis * Have routine follow-up bio

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📋 Eligibility rules (as published)
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.
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What it tests

  • Time Zero Donor Heart Biopsy for Molecular Analysis
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Where

1 site
Medical University Vienna
Vienna, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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