Understanding how diabetes affects heart function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the differences in mitochondrial substrate utilization and complex activity in the hearts of patients with heart failure and type 2 diabetes mellitus (T2DM). It will analyze myocardial mitochondrial oxidative function, metabolic parameters, gene expression, and inflammation in cardiac tissue from patients undergoing heart transplantation or with heart failure. Cardiac function will be assessed using advanced imaging techniques, including cardiac magnetic resonance imaging and spectroscopy, alongside oral glucose tolerance tests to characterize glycemic control. The findings are expected to enhance our understanding of diabetic cardiomyopathy and its underlying mechanisms.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Elric Zweck, MD — Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
• Study coordinator: Elric Zweck, MD
• Email: elric.zweck@med.uni-duesseldorf.de
• Phone: +492118118800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.