NCT06982404

ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplantation
• Graft Rejection
• Myocardial Injury
• Organ Preservation
• Biopsy
• Gene Expression Profiling

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Time 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.

Timeline

• Start date: 2025-05-12
• Primary completion: 2027-05-31
• Completion: 2028-05-31
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: Austria