Actively Recruiting

All Genders
NCT06982404

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

Led by Medical University of Vienna · Updated on 2025-05-21

50

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

Sponsors

M

Medical University of Vienna

Lead Sponsor

A

Alberta Transplant Applied Genomics Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 biopsies after transplantation as part of standard care (no additional procedures required beyond medical standard) Researchers will compare biopsy results from different donor types (standard vs. marginal, DBD vs. DCD) to see if early molecular signals are linked to later heart transplant outcomes.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Donor hearts from standard and expanded criteria donors undergoing biopsy at organ procurement
  • Donor hearts from Donation after Circulatory Death (DCD) included
  • Consent obtained from recipient at time of transplant listing
Not Eligible

You will not qualify if you...

  • Heart discarded by participating clinician before transplantation
  • Recipient declines biopsy at organ procurement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Medical University Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

Loading map...

Research Team

R

Roxana Moayedifar Principal Investigator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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