Clinical trial NCT06982404: ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
Official title: ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplantation
Graft Rejection
Myocardial Injury
Organ Preservation
Biopsy
Gene Expression Profiling
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Alberta Transplant Applied Genomics Centre
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in this study include deceased heart donors and their corresponding transplant recipients. Donors will include both standard criteria donors and expanded criteria donors, including donations after brain death (DBD) and donations after circulatory death (DCD). Right ventricular heart tissue biopsies will be obtained from these donors at the time of organ procurement. Follow-up data will be collected from the adult transplant recipients of these donor hearts, based on routine clinical care (e.g., biopsies, echocardiography, and medical records) over a 12-month post-transplant period.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Prediction of Post-Transplant Heart Function Based on Time Zero Molecular Biopsy Profiles
timeFrame: From enrollment to the end of follow-up at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References: