Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Medical University Vienna
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
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