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

Recruiting

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

• Registration Number: NCT06982404
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-12
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-05-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria