Skip to content

Multimodal Analysis of Endomyocardial Biopsies

Multimodal Analysis of Endomyocardial Biopsies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07359690
Enrollment
216
Registered
2026-01-22
Start date
2025-10-27
Completion date
2028-09-30
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis Cardiac, Cardiomyopathies, Dilated Cardiomyopathy (DCM), Heart Transplantation, Hypertrophic Cardiomyopathy (HCM), Myocarditis, Pericarditis, Sarcoidosis of the Heart

Keywords

Endomyocardial biopsy, Multimodal analysis

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Essen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Spatial molecular profiles and immune signalling in all included patientsBaseline, up to 1 yearIdentification 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.

Secondary

MeasureTime frameDescription
Tracer-Uptakes in cardiac amyloidosis.Baseline, up to 1 year.Ex vivo analysis of tracer uptake in human endomyocardial biopsy samples from patients with cardiac amyloidosis.

Countries

Germany

Contacts

CONTACTLars Michel, PD Dr. med.
lars.michel@uk-essen.de+49 0201 723 84841
PRINCIPAL_INVESTIGATORLars Michel, PD Dr. med.

Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026