Heart Transplant RejectionEMBIONCT06064123
Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
An observational study of Heart Transplant Rejection, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood leukocyte mRNA expression in recognition of clinically significant endomyocardial biopsy (EMB)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Transplant Rejection
- What is being tested?
- Cell-free DNA
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 22 Jan 2019to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population consist of heart transplant recipients transplanted at the Helsinki University Hospital, Helsinki, Finland.
Who may be able to join
- patient age > 18 years
- heart transplant recipient
- has signed informed consent
Who cannot join
- foreign residency
- no signed informed consent collected
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Uusimaa, 00029
Karl B Lemstrom, MD, PhD, +358504272281, Karl.Lemstrom@Hus.Fi
About this study
The objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood leukocyte mRNA expression in recognition of clinically significant endomyocardial biopsy (EMB) proven acute rejection in human heart transplant recipients. In detail, the objective is to develop novel biomarkers and liquid biopsies for diagnosis, prognosis, and targeted molecular therapy for primary graft failure, ischemia-reperfusion injury, acute rejection, and development of late graft failure and cardiac allograft vasculopathy, and for monitoring immunosuppression after heart transplantation.
- Conditions
- Heart Transplant Rejection
- Being tested
- Cell-free DNA
- Keywords
- Donor-derived Cell-Free DNA, Platelet, Endomyocardial biopsy, Liquid biopsy, Transcriptome, Proteomics, Metabolomics, Glycoproteins, Surveillance, Extracellular Vesicles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-free DNADiagnostic test
Donor-derived cell-free DNA relation to recipient-derived cell-free DNA is compared to histopathological rejection grade from the same time frame.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac transplant recipients | The group consist of all recruited cardiac transplant recipients operated in Helsinki University Hospital Receives: Diagnostic Test: Cell-free DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
To compare plasma dd-cfDNA to endomyocardial biopsy data
Measured: 5 years
Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of allograft-educated platelets to endomyocardial biopsy data
Measured: 5 years
Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of EV-derived mRNA to endomyocardial biopsy data
Measured: 5 years
Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
To compare plasma glycoproteome profile to endomyocardial biopsy data
Measured: 5 years
Secondary outcomes (7)
Plasma metabolomics changes during acute rejection after heart transplantation
Plasma metabolic changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation to investigate if there are any plasma metabolomics changes during different grades of acute rejection.
Measured: 1 year
Plasma proteomics changes during acute rejection after heart transplantation
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation to investigate if there are any plasma proteomics changes during different grades of acute rejection during the first year.
Measured: 1 year
Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation
To compare gene expression profile of peripheral blood mononuclear cells to endomyocardial biopsy data
Measured: 1 year
Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Plasma metabolomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
Measured: 5 years
Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Plasma metabolomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to patient survival will be investigated at 1, 3, and 5 years.
Measured: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and their relationship to the development of cardiac allograft vasculopathy in coronary angiogram will be investigated at 1, 3, and 5 years.
Measured: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Plasma proteomics changes will be measured by mass spectrometry during routine surveillance endomyocardial biopsies taken at 2, 4, 6, 8, and 12 weeks and at 4, 5, 6, 8, 10, and 12 months after heart transplantation and and their relationship to patient survival will be investigated at 1, 3, and 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start22 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Lemstrom, Helsinki University Central Hospital
- Investigators
- Karl B Lemström, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064123
- Sponsor's protocol ID
- HUS/3654/2017
- Acronym
- EMBIO
- Status last verified
- Oct 2023
- First submitted
- 20 Jun 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
- ClinicalTrials.gov ID
- NCT06064123
- Acronym / sponsor ID
- EMBIO / HUS/3654/2017
- Conditions
- Heart Transplant Rejection
- Keywords
- Donor-derived Cell-Free DNA, Platelet, Endomyocardial biopsy, Liquid biopsy, Transcriptome, Proteomics, Metabolomics, Glycoproteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Oct 2023 (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 objective of this prospective observational single center study is to investigate donor-derived cell-free DNA (ddcfDNA), peripheral blood platelet mRNA, peripheral blood extracellular vesicle mRNA, and peripheral blood leukocyte mRNA expression in recognition of clinically significant endomyocardial biopsy (EMB) proven acute rejection in human heart transplant recipients. In detail, the objective is to develop novel biomarkers and liquid biopsies for diagnosis, prognosis, and targeted molecular therapy for primary graft failure, ischemia-reperfusion injury, acute rejection, and development of late graft failure and cardiac allograft vasculopathy, and for monitoring immunosuppression after heart transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac transplant recipients | – | Diagnostic Test: Cell-free DNAThe group consist of all recruited cardiac transplant recipients operated in Helsinki University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consist of heart transplant recipients transplanted at the Helsinki University Hospital, Helsinki, Finland.
Key inclusion criteria (3 listed)
- patient age > 18 years
- heart transplant recipient
- has signed informed consent
Key exclusion criteria (2 listed)
- foreign residency
- no signed informed consent collected
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 |
|---|---|---|
| Cell-free DNADonor-derived cell-free DNA relation to recipient-derived cell-free DNA is compared to histopathological rejection grade from the same time frame. | Diagnostic test | Cardiac transplant recipients |
Primary outcome
Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation
Time frame: 5 years
To compare plasma dd-cfDNA to endomyocardial biopsy data
Allograft educated platelet-derived mRNA for gene expression profiling of acute rejection after heart transplantation
Time frame: 5 years
To compare gene expression profile of allograft-educated platelets to endomyocardial biopsy data
Plasma extracellular vesicle (EV) derived mRNA for gene expression profiling of acute rejection after heart transplantation
Time frame: 5 years
To compare gene expression profile of EV-derived mRNA to endomyocardial biopsy data
Plasma glycoproteins for routine surveillance of acute rejection after heart transplantation
Time frame: 5 years
To compare plasma glycoproteome profile to endomyocardial biopsy data
7 secondary outcomes
Plasma metabolomics changes during acute rejection after heart transplantation
Time frame: 1 year
Plasma proteomics changes during acute rejection after heart transplantation
Time frame: 1 year
Peripheral blood mononuclear cell mRNA expression for gene expression profiling of acute rejection after heart transplantation
Time frame: 1 year
Plasma metabolomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Time frame: 5 years
Plasma metabolomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Time frame: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to the development of cardiac allograft vasculopathy
Time frame: 5 years
Plasma proteomics changes during the first year after heart transplantation and their relationship to patient survival at 1, 3, and 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Karl B Lemström, MD, PhD principal investigator
Helsinki University Central Hospital
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 Transplant Rejection, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl B Lemstrom, MD, PhD (+358504272281, Karl.Lemstrom@Hus.Fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma donor-derived cell-free DNA (dd-cfDNA) for routine surveillance of acute rejection after heart transplantation (time frame: 5 years). The study lists 4 primary outcomes in all. 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 3 Oct 2023.