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Heart tissue analysis aims to unlock better diagnosis

NCT ID NCT07359690

Knowledge-focused Sponsor: University Hospital, Essen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at heart tissue samples from 216 adults who already need a biopsy as part of their care. Researchers want to find unique molecular patterns in different heart conditions, including after a heart transplant. The goal is to improve how these diseases are diagnosed and treated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Amyloid Neuropathies, Familial cardiac sarcoidosis cardiomyopathy dilated cardiomyopathy hypertrophic cardiomyopathy myocarditis pericarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidosis cardiac Cardiomyopathies Dilated cardiomyopathy (DCM) Heart transplantation Hypertrophic cardiomyopathy (HCM) Myocarditis, pericarditis Sarcoidosis of the heart

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

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