NCT05958706Recruiting
Mitochondrial Substrate Utilization in the Diabetic Human Heart
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control/T2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 3 Jul 2023
- Start date
- 1 Dec 2021
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT05958706
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Dec 2021 to the primary completion date, 30 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute infectious diseases within the last 2 weeks before the examination
Other illness
- 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
- 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.
Lab values
- Autoimmune diseases or acute immunocompromising diseases (leukocytes \< 5000/μl)
Other
- Pregnancy
- Lack of capacity to give informed consent or lack of consent to participate in the study
Who the study is looking for
- 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
Age in the registry: 20 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.