Heart TransplantationTRANSCENDNCT07886489
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
An observational study of Heart Transplantation, run by University of Aarhus at 3 sites in 2 countries.
Trial summary
Following heart transplantation (HTx), lifelong immunosuppressive treatment is required to prevent the immune system from attacking, damaging, and rejecting the donor hear (allograft). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- What is being tested?
- Donor-derived cell free DNA
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Sep 2026to 31 Aug 2038
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing heart transplantation at Rigshospitalet Copenhagen, Denmark, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark
Who may be able to join
- Patients entering the waiting list for their first heart transplantation (HTX1) at Rigshospitalet Copenhagen, Denmark, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark
- Patients ≥18 years old
- Patients signing informed consent
Who cannot join
- Patients who are withdrawn from the heart transplant waiting list after informed consent has been provided
- Patients who have previously received a solid organ transplantation
- Patients unable to receive and understand the oral and written project information
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Denmark2 sites
Aarhus University Hospital
Aarhus, 8200
Rigshospitalet Copenhagen
Copenhagen, 2100
About this study
Following heart transplantation (HTx), lifelong immunosuppressive treatment is required to prevent the immune system from attacking, damaging, and rejecting the donor hear (allograft). Currently, diagnosis of allograft rejection is based on evaluation of endomyocardial biopsies (EMB), which remains the gold standard for rejection diagnostics. However, previous research have highlighted limitations of EMBs, including interrater variation, sampling error and risks of complications.
Donor-derived cell-free DNA (dd-cfDNA) has emerged as a promising post-transplant biomarker of allograft rejection. Nevertheless, evidence suggests that dd-cfDNA demonstrates greater diagnostic performance for antibody-mediated rejection (AMR) than for cellular rejection (TCR) and that the specificity exceeds its sensitivity in predicting rejection, highlighting limitations in its clinical application.
Read more
The primary objective of this observational project are to investigate if measurement of dd-cfDNA can be utilized as a biomarker for acute rejection in the management of heart transplant recipients during the first year after transplantation in a Danish-Norwegian patient cohort.
Secondary objectives include:
- to correlate dd-cfDNA levels with markers of allograft dysfunction and rejection, i.e., EMBs, ejection fraction, left ventricular global longitudinal strain, troponin T, natriuretic peptide test (proBNP) and score of cardiac allograft vasculopathy (CAV)
- to examine post-transplant dd-cfDNA kinetics during the first 6 six weeks after HTx
- to explore clinical meaningful change in dd-cfDNA associated with acute allograft rejection
- to investigate the association between dd-cfDNA, chronic allograft rejection, allograft dysfunction and patients' long-term survival
To study the objectives, this project will include 100 HTx patients prior to transplantation over a 2-3 year period and conduct a long-time follow up 10 years after transplantation. Patients entering the waiting list for HTx at Rigshospitalet Copenhagen, Denmark, Oslo University Hospital, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark, are invited to participate in the project. Patients are invited to participate in the current project if fulfilling the pre-defined inclusion criteria and no exclusion criteria.
A comprehensive collection of clinical, pathological and immunological data is conducted from up to 15 visits during the first year after transplantation. Thereafter, from all annual visits and upon admission if allograft rejection is suspected.
- Conditions
- Heart Transplantation
- Being tested
- Donor-derived cell free DNA
- Keywords
- Heart transplantation, Heart Failure, Donor-derived cell free DNA
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor-derived cell free DNADiagnostic test
Blood samples from months 1, 3, 6 and 12, and upon suspected allograft rejection, will be analysed to quantify dd-cfDNA studying the primary objective. To study additional objectives dd-cfDNA is further analyzed yearly after year 1 in all included patients. In a subgroup of patients without allograft rejection, dd-cfDNA will be analyed weekly within the first 6 weeks after transplantation to study normal dd-cfDNA kinetics after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Heart transplant recipients | Not described Receives: Diagnostic Test: Donor-derived cell free DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between dd-cfDNA level and acute allograft rejection (TCR and AMR) in the first year after transplantation, which will be evaluated using a linear mixed model and reported as the model estimate for the fixed effect (allograft rejection)
Measured: From baseline to one year follow up
Secondary outcomes (6)
Association between dd-cfDNA level and acute allograft rejection in the 3rd, 5th and 10th year after transplantation implementing linear mixed models and reported as the model estimate for the fixed effect (allograft rejection)
Measured: From baseline to 10 year follow up
The area under the ROC curve (AUROC) depicting the performance of dd-cfDNA to distinguish between acute allograft rejection or no rejection in the 1st, 3rd, 5th and 10th year after transplantation.
Measured: From baseline to 10 ten year follow up
The sensitivity and positive predictive value (PPV) of dd-cfDNA as a biomarker of allograft rejection, i.e., the proportion of positive results (increased dd-cfDNA) that are true positive (developed rejection) after 1, 3, 5 and 10 years
Measured: Baseline to 10 year follow up
The specificity and negative predictive value (NPV) of dd-cfDNA as a biomarker of acute allograft rejection, i.e., the proportion of negative results (decreased/no change in dd-cfDNA) that are true negative (no rejection) after 1, 3, 5 and 10 years
Measured: Baseline to 10 year follow up
Change in the fraction of dd-cfDNA (dd-cfDNA kinetics) in patients without allograft rejection in the first six weeks after transplantation
Measured: Baseline to 6 weeks afters transplantation
Correlation between dd-cfDNA level, clinical findings (GLS, biopsy results, etc.) and patient characteristics
Measured: Baseline to 1, 3, 5, and 10 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Sep 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2038 (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 University of AarhusThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886489
- Sponsor's protocol ID
- 1-10-72-67-25
- Acronym
- TRANSCEND
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to restrictions imposed by Danish and Norwegian data protection legislation, individual participant-level data cannot be made publicly available or shared with third party. Project data may be made available upon reasonable request and subject to appropriate collaboration agreements, in accordance with applicable Danish and Norwegian data protection legislation.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT07886489
- Acronym / sponsor ID
- TRANSCEND / 1-10-72-67-25
- Conditions
- Heart Transplantation
- Keywords
- Heart transplantation, Heart Failure, Donor-derived cell free DNA
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet, Oslo University Hospital
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2038 (estimated)
- First posted
- 21 Oct 2026 (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.
Following heart transplantation (HTx), lifelong immunosuppressive treatment is required to prevent the immune system from attacking, damaging, and rejecting the donor hear (allograft). Currently, diagnosis of allograft rejection is based on evaluation of endomyocardial biopsies (EMB), which remains the gold standard for rejection diagnostics. However, previous research have highlighted limitations of EMBs, including interrater variation, sampling error and risks of complications.
Donor-derived cell-free DNA (dd-cfDNA) has emerged as a promising post-transplant biomarker of allograft rejection. Nevertheless, evidence suggests that dd-cfDNA demonstrates greater diagnostic performance for antibody-mediated rejection (AMR) than for cellular rejection (TCR) and that the specificity exceeds its sensitivity in predicting rejection, highlighting limitations in its clinical application.
The primary objective of this observational project are to investigate if measurement of dd-cfDNA can be utilized as a biomarker for acute rejection in the management of heart transplant recipients during the first year after transplantation in a Danish-Norwegian patient cohort.
Secondary objectives include:
- to correlate dd-cfDNA levels with markers of allograft dysfunction and rejection, i.e., EMBs, ejection fraction, left ventricular global longitudinal strain, troponin T, natriuretic peptide test (proBNP) and score of cardiac allograft vasculopathy (CAV)
- to examine post-transplant dd-cfDNA kinetics during the first 6 six weeks after HTx
- to explore clinical meaningful change in dd-cfDNA associated with acute allograft rejection
- to investigate the association between dd-cfDNA, chronic allograft rejection, allograft dysfunction and patients' long-term survival
To study the objectives, this project will include 100 HTx patients prior to transplantation over a 2-3 year period and conduct a long-time follow up 10 years after transplantation. Patients entering the waiting list for HTx at Rigshospitalet Copenhagen, Denmark, Oslo University Hospital, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark, are invited to participate in the project. Patients are invited to participate in the current project if fulfilling the pre-defined inclusion criteria and no exclusion criteria.
A comprehensive collection of clinical, pathological and immunological data is conducted from up to 15 visits during the first year after transplantation. Thereafter, from all annual visits and upon admission if allograft rejection is suspected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart transplant recipients | – | Diagnostic Test: Donor-derived cell free DNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing heart transplantation at Rigshospitalet Copenhagen, Denmark, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark
Key inclusion criteria (3 listed)
- Patients entering the waiting list for their first heart transplantation (HTX1) at Rigshospitalet Copenhagen, Denmark, Rikshospitalet Oslo, Norway, or Aarhus University Hospital, Denmark
- Patients ≥18 years old
- Patients signing informed consent
Key exclusion criteria (3 listed)
- Patients who are withdrawn from the heart transplant waiting list after informed consent has been provided
- Patients who have previously received a solid organ transplantation
- Patients unable to receive and understand the oral and written project information
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 |
|---|---|---|
| Donor-derived cell free DNABlood samples from months 1, 3, 6 and 12, and upon suspected allograft rejection, will be analysed to quantify dd-cfDNA studying the primary objective. To study additional objectives dd-cfDNA is further analyzed yearly after year 1 in all included patients. In a subgroup of patients without allograft rejection, dd-cfDNA will be analyed weekly within the first 6 weeks after transplantation to study normal dd-cfDNA kinetics after transplantation. | Diagnostic test | Heart transplant recipients |
Primary outcome
Association between dd-cfDNA level and acute allograft rejection (TCR and AMR) in the first year after transplantation, which will be evaluated using a linear mixed model and reported as the model estimate for the fixed effect (allograft rejection)
Time frame: From baseline to one year follow up
6 secondary outcomes
Association between dd-cfDNA level and acute allograft rejection in the 3rd, 5th and 10th year after transplantation implementing linear mixed models and reported as the model estimate for the fixed effect (allograft rejection)
Time frame: From baseline to 10 year follow up
The area under the ROC curve (AUROC) depicting the performance of dd-cfDNA to distinguish between acute allograft rejection or no rejection in the 1st, 3rd, 5th and 10th year after transplantation.
Time frame: From baseline to 10 ten year follow up
The sensitivity and positive predictive value (PPV) of dd-cfDNA as a biomarker of allograft rejection, i.e., the proportion of positive results (increased dd-cfDNA) that are true positive (developed rejection) after 1, 3, 5 and 10 years
Time frame: Baseline to 10 year follow up
The specificity and negative predictive value (NPV) of dd-cfDNA as a biomarker of acute allograft rejection, i.e., the proportion of negative results (decreased/no change in dd-cfDNA) that are true negative (no rejection) after 1, 3, 5 and 10 years
Time frame: Baseline to 10 year follow up
Change in the fraction of dd-cfDNA (dd-cfDNA kinetics) in patients without allograft rejection in the first six weeks after transplantation
Time frame: Baseline to 6 weeks afters transplantation
Correlation between dd-cfDNA level, clinical findings (GLS, biopsy results, etc.) and patient characteristics
Time frame: Baseline to 1, 3, 5, and 10 year follow up
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 Oct 2026.
- Individual participant dataSharing planned: Undecided. Due to restrictions imposed by Danish and Norwegian data protection legislation, individual participant-level data cannot be made publicly available or shared with third party. Project data may be made available upon reasonable request and subject to appropriate collaboration agreements, in accordance with applicable Danish and Norwegian data protection legislation.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation, run by University of Aarhus at 3 sites in 2 countries.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between dd-cfDNA level and acute allograft rejection (TCR and AMR) in the first year after transplantation, which will be evaluated using a linear mixed model and reported as the model estimate for the fixed effect (allograft rejection) (time frame: From baseline to one year follow up). 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 Oct 2026.