Multimodal Analysis of Endomyocardial Biopsies

University Hospital Essen

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07359690

WHGZ-EMB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

216 participants in 1 patient group

Patients undergoing endomyocardial biopsy following clinical indication

Description:

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.