Actively Recruiting

Age: 20Years - 85Years
All Genders
NCT05958706

Mitochondrial Substrate Utilization in the Diabetic Human Heart

Led by Heinrich-Heine University, Duesseldorf · Updated on 2026-02-19

500

Participants Needed

1

Research Sites

704 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mitochondrial Substrate Utilization in the Diabetic Human Heart

Who Can Participate

Age: 20Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 to 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
Not Eligible

You will not qualify if you...

  • 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 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
  • Contraindications to regadenoson for MRI stress test such as hypersensitivity, certain heart conduction blocks without pacemaker, unstable angina, severe hypotension, or decompensated heart failure

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Düsseldorf, Germany, 40225

Actively Recruiting

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Research Team

E

Elric Zweck, MD

CONTACT

A

Amin Polzin, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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