Actively Recruiting
Mitochondrial Substrate Utilization in the Diabetic Human Heart Observational Study of Heart Failure and Type 2 Diabetes
Led by Heinrich-Heine University, Duesseldorf · Updated on 2026-02-19
500
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates how diabetes, particularly type 2 diabetes mellitus (T2DM), affects heart failure by studying the function of mitochondria in the heart muscle. Researchers aim to understand the changes in mitochondrial metabolism and how these relate to diabetic cardiomyopathy, a type of heart dysfunction seen in diabetic patients. This observational study focuses on patients with heart failure or those who have undergone heart transplantation, examining the underlying cellular mechanisms to guide early diagnosis and treatment strategies. Participants are grouped based on their heart failure status and presence of T2DM, including patients with manifest heart failure, terminal heart failure, and those after heart transplantation. The study collects heart tissue samples through biopsies or surgery to analyze mitochondrial function and related metabolic markers. Cardiac function is assessed using magnetic resonance imaging (MRI) with stress tests and magnetic resonance spectroscopy, along with oral glucose tolerance tests to evaluate glycemic control. Throughout the study, participants undergo various assessments including myocardial biopsies, imaging, and metabolic tests. Researchers measure the heart muscle's mitochondrial oxidative capacity, cardiac structure and function markers, gene expression, and inflammation. Long-term clinical outcomes such as myocardial infarction, mortality, rejection after transplant, and hospitalization for heart failure are monitored for up to five years. This comprehensive approach aims to clarify how diabetes affects heart muscle metabolism and function over time.
CONDITIONS
Brief Title
Mitochondrial Substrate Utilization in the Diabetic Human Heart
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 to 85 years
- Male and female patients with manifest heart failure (NYHA II-IV) or after heart transplantation with clinical indication for myocardial biopsy
- Patients with or without type II diabetes mellitus
- Ability to provide written informed consent
You will not qualify if you...
- Acute infectious diseases within the last 2 weeks before examination
- Autoimmune diseases or acute immunocompromising diseases (leukocytes < 5000/µl)
- Pregnancy
- Use of alcohol or drugs (addiction), psychiatric diseases
- Suspected or confirmed AIDS (HIV), hepatitis B or C
- Liver disease not related to nonalcoholic fatty liver hepatitis or heart failure
- Malignant cancer
- Lack of capacity or refusal to consent to participate
- Contraindications to regadenoson for MRI stress test, including hypersensitivity, certain heart blocks without pacemaker, unstable angina, severe hypotension, or decompensated heart failure
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on clinical indication
Participants undergo myocardial biopsy procedures to obtain heart tissue samples for analysis of mitochondrial function and cardiac health.
1 biopsy procedure visit
Duration - Up to 5 years
Participants are monitored for clinical outcomes such as cardiac function, all-cause mortality, and graft rejection over several years following biopsy or surgery.
Multiple visits annually as part of routine clinical follow-up
Trial Site Locations
Total: 1 location
1
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, Germany, 40225
Actively Recruiting
Research Team
E
Elric Zweck, MD
A
Amin Polzin, MD
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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