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Clinical trial Recruiting at 1 site Observational

Predicting heart transplant outcomes using donor heart biopsies

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

Run by Medical University of Vienna · NCT06982404 · Data updated 2026-11-12

This study is testing if looking at tissue samples from donor hearts can help predict how well the transplanted hearts will work and if they'll be rejected by the recipient's body.

Quick facts

Study typeObservational
SexAll
Enrollment50 (estimated)
SponsorMedical University of Vienna
Academic / other
Locations1 site (Vienna, State of Vienna)
StatusRecruiting
StartedMay 12, 2025
Main results expectedMay 31, 2027
Study endsMay 31, 2028
Registry record updatedMay 21, 2025
Trial IDNCT06982404 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are heart transplant recipients from both standard and marginal donor hearts, including those from donation after circulatory death.

Probably not a fit

Patients whose donor hearts are discarded prior to transplantation or who decline the biopsy will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the potential of molecular analysis of donor heart biopsies taken at the time of organ removal to predict the future function and rejection risk of transplanted hearts. It will assess whether early molecular injury in the donor heart can be detected and if these findings can forecast short-, mid-, and long-term transplant outcomes. Participants will include heart donors from various criteria, and biopsies will be taken for both routine pathology and advanced molecular analysis. Follow-up biopsies will occur post-transplant as part of standard care.

Why it matters

Potential benefit: If successful, this approach could lead to improved prediction of transplant outcomes, enhancing patient care and graft longevity.

How similar studies have gone: While similar approaches in organ transplantation have been explored, this specific methodology of using pre-transplant biopsies for predictive analysis is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Medical University Vienna
    Vienna, State of Vienna, Austria     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Heart Transplantation 36Graft Rejection 6Myocardial Injury 29Organ Preservation 5Medical University of Vienna 121
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.