Multimodal Analysis of Endomyocardial Biopsies

NCT07359690 | Recruiting

• 1 other identifier: WHGZ-EMB
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Endomyocardial biopsy; Multimodal analysis

Outcome Measures

Primary Outcomes (1)

• Spatial molecular profiles and immune signalling in all included patients

  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.

  Baseline, up to 1 year

Secondary Outcomes (1)

• Tracer-Uptakes in cardiac amyloidosis.

  Baseline, up to 1 year.

Study Arms (1)

Patients undergoing endomyocardial biopsy following clinical indication

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients receiving an endomyocardial biopsy after routine clinical indication will be enrolled. The identification of molecular profiles from the obtained endomyocardial biopsies (EMBs) represents an exploratory research approach that does not allow for an exact sample size calculation. Considering the heterogeneity of the collected EMBs, and particularly the fact that EMBs are often performed for the differential diagnosis of various rare myocardial diseases, an adequately large study population is necessary to capture rare phenotypes. The planned cohort will include 40 patients each from the main groups: unclear cardiomyopathy, suspected (ICI-)myocarditis, suspected cardiac storage disease, and post-heart transplantation surveillance. Thus, a total of 160 EMBs are targeted for multi-omics analysis.The secondary endpoint of the study allows for a sample size estimation of 56 EMBs for the subgroup of cardiac amyloidosis (calculation according to the full proposal).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

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

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Endomyocardial biopsy samples containing DNA for further multi-omics assessment.

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Myocarditis; Pericarditis; Amyloid Neuropathies, Familial; Cardiomyopathies

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Lars Michel, PD Dr. med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Michel, PD Dr. med.

CONTACT

+49 0201 723 84841; lars.michel@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiomyopathies and Heart Failure

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 22, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

DE (1)