Multimodal Analysis of Endomyocardial Biopsies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Transplantation, Dilated Cardiomyopathy (DCM), Hypertrophic Cardiomyopathy (HCM), Myocarditis, Pericarditis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Spatial molecular profiles and immune signalling in all included patients [Time frame: Baseline, up to 1 year]
Secondary outcome measures (1)
- Tracer-Uptakes in cardiac amyloidosis. [Time frame: Baseline, up to 1 year.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Esse — Essen
Identifiers
NCT: NCT07359690 · WHGZ-EMB