NCT05958706 Mitochondrial Substrate Utilization in the Diabetic Human Heart
| NCT ID | NCT05958706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heinrich-Heine University, Duesseldorf |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2021-12-01 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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.
Contact & Investigator
Malte Kelm, Prof.
STUDY CHAIR
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Frequently Asked Questions
Who can join the NCT05958706 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 85 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05958706 currently recruiting?
Yes, NCT05958706 is actively recruiting participants. Contact the research team at elric.zweck@med.uni-duesseldorf.de for enrollment information.
Where is the NCT05958706 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT05958706 clinical trial?
NCT05958706 is sponsored by Heinrich-Heine University, Duesseldorf. The principal investigator is Malte Kelm, Prof. at Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf. The trial plans to enroll 500 participants.
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