Heart TransplantationNCT07359690
Multimodal Analysis of Endomyocardial Biopsies
An observational study of Heart Transplantation and Dilated Cardiomyopathy (DCM), run by University Hospital, Essen at 1 site in Germany.
Trial summary
The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM)
- How many people
- 216 participants
- Where
- 1 siteGermany
- Study dates
- 27 Oct 2025to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving an endomyocardial biopsy after routine clinical indication will be enrolled. The identification of molecular profiles from the obtained endomyocardial biopsies (EMBs) represents an exploratory research approach that does not allow for an exact sample size calculation. Considering the heterogeneity of the collected EMBs, and particularly the fact that EMBs are often performed for the differential diagnosis of various rare myocardial diseases, an adequately large study population is necessary to capture rare phenotypes. The planned cohort will include 40 patients each from the main groups: unclear cardiomyopathy, suspected (ICI-)myocarditis, suspected cardiac storage disease, and post-heart transplantation surveillance. Thus, a total of 160 EMBs are targeted for multi-omics analysis.The secondary endpoint of the study allows for a sample size estimation of 56 EMBs for the subgroup of cardiac amyloidosis (calculation according to the full proposal).
Who may be able to join
- Patients aged >18 years with a clinical indication for endomyocardial biopsy.
- Patients capable of providing informed consent who have signed the consent form for participation in the study.
Who cannot join
- Patients without a clinical indication for endomyocardial biopsy (EMB).
- Pregnant individuals.
- Patients incapable of providing informed consent.
- Women of childbearing potential who are not using adequate contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany
Essen, North Rhine-Westphalia, 45147
About this study
The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy.
The main aim is:
-Identification of molecular profiles (e.g., proteome, lipidome, metabolome) and immune signalling profiles that are specifically associated with different myocardial diseases and the post-heart transplantation course.
Participants already receiving an endomyocardial biopsy as part of their regular medical care will be enrolled. An additional biopsy sample will be taken for the above mentioned research.
Read the detailed description
The proposed study aims to pursue a multimodal approach to identify the molecular signatures and immune signalling profiles of various myocardial diseases and thereby contribute to improving diagnosis and therapy. In the context of a clinically indicated endomyocardial biopsy (EMB), an additional EMB will be performed. This sample will be further analyzed using, among other methods, multi-omics, immune signalling analysis and nuclear cardiology analyses. These analyses are intended to enable the identification of genetic mutations, inflammatory gene expression patterns, immune signalling and protein alterations in myocardial diseases such as cardiomyopathies, myocarditis, and cardiac amyloidosis. Furthermore, the results will be correlated with established clinical parameters and biomarkers in order to identify novel diagnostic markers.
- Conditions
- Heart Transplantation, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Myocarditis, Pericarditis, Amyloidosis Cardiac, Cardiomyopathies
- Keywords
- Endomyocardial biopsy, Multimodal analysis
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Myocarditis, Pericarditis, Amyloid Neuropathies, Familial, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing endomyocardial biopsy following clinical indication | All patients with a clinical indication for EMB without regard to certain disease types. Typically these patients are after heart transplantation, amyloidosi or with a cardiomyopathy, including dilated-, hypertrophic- or inflammatory cardiomyopathy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial molecular profiles and immune signalling in all included patients
Identification of spatial molecular profiles (e.g., proteomic, lipidomic, and metabolomic signatures) and immune signalling pathways specifically associated with various myocardial diseases and post-heart transplantation outcomes.
Measured: Baseline, up to 1 year
Secondary outcomes (1)
Tracer-Uptakes in cardiac amyloidosis.
Ex vivo analysis of tracer uptake in human endomyocardial biopsy samples from patients with cardiac amyloidosis.
Measured: Baseline, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start27 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 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.
- 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
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Michel, University Hospital, Essen
- Investigators
- Lars Michel, PD Dr. med., Principal investigator, Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359690
- Sponsor's protocol ID
- WHGZ-EMB
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analysis of Endomyocardial Biopsies
- ClinicalTrials.gov ID
- NCT07359690
- Acronym / sponsor ID
- WHGZ-EMB
- Conditions
- Heart Transplantation, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Myocarditis, Pericarditis, Amyloidosis Cardiac, Cardiomyopathies
- Keywords
- Endomyocardial biopsy, Multimodal analysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Jan 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.
The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy.
The main aim is:
-Identification of molecular profiles (e.g., proteome, lipidome, metabolome) and immune signalling profiles that are specifically associated with different myocardial diseases and the post-heart transplantation course.
Participants already receiving an endomyocardial biopsy as part of their regular medical care will be enrolled. An additional biopsy sample will be taken for the above mentioned research.
Detailed description
The proposed study aims to pursue a multimodal approach to identify the molecular signatures and immune signalling profiles of various myocardial diseases and thereby contribute to improving diagnosis and therapy. In the context of a clinically indicated endomyocardial biopsy (EMB), an additional EMB will be performed. This sample will be further analyzed using, among other methods, multi-omics, immune signalling analysis and nuclear cardiology analyses. These analyses are intended to enable the identification of genetic mutations, inflammatory gene expression patterns, immune signalling and protein alterations in myocardial diseases such as cardiomyopathies, myocarditis, and cardiac amyloidosis. Furthermore, the results will be correlated with established clinical parameters and biomarkers in order to identify novel diagnostic markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing endomyocardial biopsy following clinical indication | – | –All patients with a clinical indication for EMB without regard to certain disease types. Typically these patients are after heart transplantation, amyloidosi or with a cardiomyopathy, including dilated-, hypertrophic- or inflammatory cardiomyopathy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving an endomyocardial biopsy after routine clinical indication will be enrolled. The identification of molecular profiles from the obtained endomyocardial biopsies (EMBs) represents an exploratory research approach that does not allow for an exact sample size calculation. Considering the heterogeneity of the collected EMBs, and particularly the fact that EMBs are often performed for the differential diagnosis of various rare myocardial diseases, an adequately large study population is necessary to capture rare phenotypes. The planned cohort will include 40 patients each from the main groups: unclear cardiomyopathy, suspected (ICI-)myocarditis, suspected cardiac storage disease, and post-heart transplantation surveillance. Thus, a total of 160 EMBs are targeted for multi-omics analysis.The secondary endpoint of the study allows for a sample size estimation of 56 EMBs for the subgroup of cardiac amyloidosis (calculation according to the full proposal).
Key inclusion criteria (2 listed)
- Patients aged >18 years with a clinical indication for endomyocardial biopsy.
- Patients capable of providing informed consent who have signed the consent form for participation in the study.
Key exclusion criteria (4 listed)
- Patients without a clinical indication for endomyocardial biopsy (EMB).
- Pregnant individuals.
- Patients incapable of providing informed consent.
- Women of childbearing potential who are not using adequate contraception.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spatial molecular profiles and immune signalling in all included patients
Time frame: Baseline, up to 1 year
Identification of spatial molecular profiles (e.g., proteomic, lipidomic, and metabolomic signatures) and immune signalling pathways specifically associated with various myocardial diseases and post-heart transplantation outcomes.
1 secondary outcome
Tracer-Uptakes in cardiac amyloidosis.
Time frame: Baseline, up to 1 year.
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 22 Jan 2026.
- 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.
Lars Michel, PD Dr. med. principal investigator
Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany
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 Dilated Cardiomyopathy (DCM), run by University Hospital, Essen at 1 site in Germany.
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 2 inclusion and 4 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 22 Jan 2026. 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 Germany. 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 Lars Michel, PD Dr. med. (+49 0201 723 84841, lars.michel@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial molecular profiles and immune signalling in all included patients (time frame: Baseline, up to 1 year). 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 22 Jan 2026.