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Scientists probe heart Cells' fuel malfunction in diabetes

NCT ID NCT05958706

Knowledge-focused Sponsor: Heinrich-Heine University, Duesseldorf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 why diabetes can damage the heart even without clogged arteries. Researchers will examine heart tissue and use advanced imaging in 500 adults with heart failure, with or without type 2 diabetes. The goal is to find early warning signs and new treatment targets for diabetic heart disease.

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 500 people

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

Started

Dec 2021

Expected to finish

Jun 2035

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

Patients with heart failure with or without T2DM undergoing endomyocardial biopsy for clinical reasons (WP1), patients with terminal heart failure with or without T2DM undergoing left ventricular assist device surgery or heart transplantation (WP2), and patients after heart transplantation with and without T2DM undergoing endomyocardial biopsy for clinical reasons (post-transplant surveillance).

Ages

20 to 85 years

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: * Age ≥ 20 and ≤ 85 years * Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus. * Written informed consent Exclusion Criteria: * Acute infectious diseases within the last 2 weeks before the examination * Autoimmune diseases or acute immunocompromising diseases (leukocytes \< 5000/μl) * Pregnancy * Use of alcohol or drugs (addiction), psychiatric diseases * Suspected or manifest AIDS (HIV); hepatitis B or C. * Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure * Malignant cancer * Lack of capacity to give informed consent or lack of consent to participate in the study * For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.

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Conditions

The condition(s) this trial relates to.

Diabetic Cardiomyopathies heart failure inborn mitochondrial metabolism disorder Insulin Resistance mitochondrial disease type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetic cardiomyopathies Heart failure Insulin resistance Mitochondrial diseases TYPE2DIABETES

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

  • University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

    RECRUITING

    Düsseldorf, 40225, Germany

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