Multimodal analysis of heart biopsy samples
Multimodal Analysis of Endomyocardial Biopsies
This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT07359690 on ClinicalTrials.gov |
What this trial studies
In patients already undergoing a clinically indicated endomyocardial biopsy, the study collects one additional biopsy sample for research. The tissue will undergo multimodal laboratory testing including multi-omics (proteome, lipidome, metabolome), immune signalling analyses, and nuclear cardiology-related assays. Results will be compared with clinical parameters, biomarkers, and diagnostic data to identify molecular profiles linked to specific myocardial diseases and post-transplant courses. The goal is to discover diagnostic markers and mechanistic insights that could guide future diagnostics or therapy development.
Who should consider this trial
Good fit: Adults (over 18) who already have a clinical indication for an endomyocardial biopsy and can give informed consent are the ideal candidates.
Not a fit: People who are not having an endomyocardial biopsy, minors, pregnant individuals, or those unable to give informed consent are not eligible and will not receive direct benefit from participation, since this is observational research.
Why it matters
Potential benefit: If successful, the work could lead to more precise diagnostic markers and better-targeted treatments for different myocardial diseases and transplant complications.
How similar studies have performed: Previous multi-omics and immune profiling studies of heart tissue have shown promise in identifying disease-associated signatures, but comprehensive multimodal approaches combining several omics and signalling analyses are still relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Essen, North Rhine-Westphalia
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany — Essen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Lars Michel, PD Dr. med. — Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany
- Study coordinator: Lars Michel, PD Dr. med.
- Email: lars.michel@uk-essen.de
- Phone: +49 0201 723 84841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.