Studying Heart Energy Use in People With Diabetes and Heart Failure
Observes heart energy processes in adults with heart failure and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Mitochondrial Substrate Utilization in the Diabetic Human Heart
Key facts
- Where
- Düsseldorf, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 85 years old?
Source: NCT05958706, who can take part
Where in Germany
- University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular MedicineDüsseldorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heinrich-Heine University, Duesseldorf
- Trial code
- NCT05958706
- Record updated
- 19 February 2026
- Original description
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.Read full original descriptionShow less
Mitochondrial Substrate Utilization in the Diabetic Human Heart
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.
Inclusion: 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: Acute infectious diseases within the last 2 weeks before the examination; 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; Autoimmune diseases or acute immunocompromising diseases (leukocytes < 5000/μl); Pregnancy; Lack of capacity to give informed consent or lack of consent to participate in the study.