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
52 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
This research aims to assess whether molecular analysis of donor heart biopsies taken at the time of organ removal can predict how well the transplanted heart will function and the risk of rejection in adult heart transplant recipients. It focuses on detecting early molecular injury caused by brain death or circulatory death and evaluating how these findings relate to short-, mid-, and long-term outcomes after transplantation. The study involves collecting two small biopsies from donor hearts at the time of organ removal: one for routine pathology and one for detailed molecular analysis using microarray technology. These biopsies come from both standard and marginal donors, including those after brain death and circulatory death, and the molecular profiles are compared to see if early injury signals correspond to later transplant success or complications. Participants include donors whose hearts are transplanted, and recipients who provide consent at transplant listing. Follow-up biopsies are performed as part of usual care after transplantation, with no extra procedures required for the study. Researchers will monitor transplant outcomes up to 12 months, focusing on how well the heart functions based on molecular biopsy results taken at "Time Zero."
CONDITIONS
Brief 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...
- All hearts from standard and expanded criteria donors are included
- Donor hearts from Donation after circulatory death (DCD) undergoing biopsy at organ procurement are included
- Consent must be obtained from the recipient at the time of transplant listing
You will not qualify if you...
- Hearts discarded before transplantation by the clinician are excluded
- Recipients who decline biopsy at organ procurement are excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 1 day
Participants undergo a right ventricular myocardial biopsy from the donor heart at the time of organ procurement for molecular analysis. This biopsy is performed once and does not alter the recipient's standard clinical care.
1 biopsy procedure at organ procurement
Duration - Up to 12 months
Participants are observed for up to 12 months after transplantation to assess post-transplant heart function based on molecular biopsy profiles.
Visits as per routine clinical follow-up
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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