Biopsy, Gene Expression Profiling, Graft Rejection, Heart Transplantation, Myocardial Injury, Organ Preservation
Conditions
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.
Interventions
DIAGNOSTIC_TESTTime Zero Donor Heart Biopsy for Molecular Analysis
This intervention involves obtaining a right ventricular myocardial biopsy from the donor heart at the time of organ procurement (Time Zero), prior to transplantation. The biopsy is divided into two parts: one for routine histopathological evaluation and the other preserved in RNAlater® for molecular analysis using microarray technology. This molecular profiling is designed to detect early tissue injury and gene expression patterns associated with graft viability and transplant outcomes. The intervention is performed only once per donor and does not alter the standard clinical care of the recipient.
Sponsors
Alberta Transplant Applied Genomics Centre
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of Post-Transplant Heart Function Based on Time Zero Molecular Biopsy Profiles | From enrollment to the end of follow-up at 12 months | This outcome assesses whether gene expression patterns identified in right ventricular heart tissue biopsies taken at the time of organ procurement (Time Zero) can predict the function of the transplanted heart over a 12-month period. The biopsies are analyzed using microarray technology to detect molecular signs of tissue injury or inflammation present before transplantation. Post-transplant heart function will be evaluated through: Routine endomyocardial biopsies performed at standard clinical timepoints (2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year) to assess for signs of graft rejection or injury Echocardiography to measure cardiac function (e.g., ejection fraction, wall motion) Clinical indicators such as the need for mechanical circulatory support or other interventions The goal is to determine whether specific molecular markers in the donor biopsy are associated with better or worse transplant outcomes, such as rejection episodes or reduced cardiac function |
Countries
Austria
Contacts
Primary ContactRoxana Moayedifar Principal Investigator
Outcome results
None listed