Recruiting

NCT Number: NCT06982404

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Roxana Moayedifar Principal Investigator, MD, PhD

CONTACT

[email protected]

+43 1 40400 52620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time Zero Donor Heart Biopsy for Molecular Analysis

Diagnostic Test

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.

Primary outcomes

Prediction of Post-Transplant Heart Function Based on Time Zero Molecular Biopsy Profiles

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Roxana Moayedifar Principal Investigator

CONTACT

[email protected]

+43 1 40400 52620

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

Alberta Transplant Applied Genomics Centre

Registry information

Acronym: ZeroHeart

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: May 21, 2025
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed