ClinicalTrials.gov record NCT07359690
Multimodal Analysis of Endomyocardial Biopsies
Multimodal Analysis of Endomyocardial Biopsies
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study enrolls adults undergoing a clinically indicated endomyocardial biopsy and collects one additional research sample during that procedure. The extra biopsy will be analyzed with multi-omics, immune signalling, and nuclear cardiology methods. Analyses and correlations with clinical data are planned at baseline and up to one year.
What it is studying. Whether distinct molecular (proteomic, lipidomic, metabolomic) and immune signalling profiles in biopsy samples differ by myocardial disease or post-transplant status, and how those profiles relate to clinical measures.
What the researchers hope to learn. To identify spatial molecular signatures and immune signalling pathways linked to different myocardial diseases and post-transplant status; to detect genetic, inflammatory gene expression, and protein alterations in myocardial disease; and to correlate molecular findings with clinical parameters to find potential diagnostic markers.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you join, an additional endomyocardial biopsy (heart tissue sample) will be taken at the time of your clinically indicated EMB. The extra biopsy will be analysed with multi-omics and immune-signalling methods; for cardiac amyloidosis cases, ex vivo tracer-uptake analysis may be performed. The study will collect and link your existing clinical data and biomarkers with the biopsy results, and data may be followed for up to one year. You must sign informed consent before any study procedures.
How the study is structured. A prospective observational cohort: people having a clinically indicated endomyocardial biopsy give one extra research biopsy sample; samples undergo multi-omics, immune signalling, and nuclear cardiology analyses and are compared with clinical data (follow-up through baseline to one year).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Oct 27, 2025
- Primary completion
- Sep 30, 2028 (estimated)
- Study completion
- Sep 30, 2028 (estimated)
- Target enrollment
- 216 participants (estimated)
- Last updated on registry
- Jan 22, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Essen
- Principal investigator
- Lars Michel, Head of Cardiomyopathies and Heart Failure
University Hospital, Essen
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Lars Michel, PD Dr. med. 📞 +49 0201 723 84841 ✉ lars.michel@uk-essen.de
Participating sites (1)
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, GermanyRecruiting
Essen, North Rhine-Westphalia, 45147 · Germany
Terms used on this page · explanations by MedicalUpdates.ai
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials