Multimodal Analysis of Endomyocardial Biopsies

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.

Recruiting

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Key information

Conditions

Heart Transplantation Amyloid Neuropathies Amyloid Neuropathies, Familial Amyloidosis Amyloidosis Cardiac Amyloidosis, Familial Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dilated Cardiomyopathy (DCM) Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Heredodegenerative Disorders, Nervous System Hypertrophic Cardiomyopathy (HCM) Laminopathies Metabolic Diseases Metabolism, Inborn Errors Myocarditis Myocarditis, Pericarditis Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pericarditis Peripheral Nervous System Diseases Proteostasis Deficiencies Sarcoidosis of the Heart

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Essen, North Rhine-Westphalia, 45147, Germany

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Tracer-Uptakes in cardiac amyloidosis.

Time frame: Baseline, up to 1 year.

Ex vivo analysis of tracer uptake in human endomyocardial biopsy samples from patients with cardiac amyloidosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Lars Michel, PD Dr. med.

CONTACT

[email protected]

+49 0201 723 84841

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jan 22, 2026
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting