Predicting heart transplant outcomes using donor heart biopsies
ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
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 type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06982404 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients whose donor hearts are discarded prior to transplantation or who decline the biopsy will not benefit from this study.
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 performed: While similar approaches in organ transplantation have been explored, this specific methodology of using pre-transplant biopsies for predictive analysis is relatively novel.
Eligibility criteria
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 this trial is running
Vienna, State of Vienna
- Medical University Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Roxana Moayedifar Principal Investigator
- Email: roxana.moayedifar@meduniwien.ac.at
- Phone: +43 1 40400 52620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.