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.
Eligibility
Sex
ALL
Min age
20 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Substrate-specific JVO2 of ventricular myocardial mitochondrial oxidative capacity — at time of the endomyocardial biopsy procedure measured in (pmol/s\*mg)
Trial sites (1)
Facility
City
Region
Status
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf
Germany
Recruiting
More Heinrich-Heine University, Duesseldorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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