Heart TransplantationZeroHeartNCT06982404
ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
An observational study of Heart Transplantation and Graft Rejection, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplantation, Graft Rejection, Myocardial Injury
- What is being tested?
- Time Zero Donor Heart Biopsy for Molecular Analysis
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 12 May 2025to 31 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna
Vienna, State of Vienna, 1090
Roxana Moayedifar Principal Investigator, MD, PhD, +43 1 40400 52620, roxana.moayedifar@meduniwien.ac.at
About this 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:
Read more
- 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
- Being tested
- Time Zero Donor Heart Biopsy for Molecular Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Zero Donor Heart Biopsy for Molecular AnalysisDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Post-Transplant Heart Function Based on Time Zero Molecular Biopsy Profiles
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
Measured: From enrollment to the end of follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start12 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Transplant Applied Genomics Centre
- Responsible party
- Principal investigator, Roxana Moayedifar, MD PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982404
- Sponsor's protocol ID
- 2032/2024
- Acronym
- ZeroHeart
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, anonymized individual participant data (IPD) collected during the study will be shared with qualified researchers upon reasonable request. The data will include molecular profiling results, clinical outcome measures, and associated metadata, and will be handled and stored by ATAGC (Alberta Transplant Applied Genomics Centre) in compliance with privacy regulations and ethical standards. All shared data will be fully de-identified to protect participant confidentiality. Requests for access will be reviewed and approved by the study's data access committee.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study
- ClinicalTrials.gov ID
- NCT06982404
- Acronym / sponsor ID
- ZeroHeart / 2032/2024
- Conditions
- Heart Transplantation, Graft Rejection, Myocardial Injury, Organ Preservation, Biopsy, Gene Expression Profiling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Alberta Transplant Applied Genomics Centre
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Zero Donor Heart Biopsy for Molecular AnalysisThis 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. | Diagnostic test | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. Yes, anonymized individual participant data (IPD) collected during the study will be shared with qualified researchers upon reasonable request. The data will include molecular profiling results, clinical outcome measures, and associated metadata, and will be handled and stored by ATAGC (Alberta Transplant Applied Genomics Centre) in compliance with privacy regulations and ethical standards. All shared data will be fully de-identified to protect participant confidentiality. Requests for access will be reviewed and approved by the study's data access committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation and Graft Rejection, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxana Moayedifar Principal Investigator (+43 1 40400 52620, roxana.moayedifar@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.