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NCT03386864 Clinical Trial

Metabolic Determinants of Cardiac Function

Heart Failure Clinical Trial

Official title:
Metabolic Determinants of Cardiac Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03386864
Other study ID # 5263R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date April 2020

Study information
Verified date August 2023
Source German Diabetes Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of cardiac energy metabolism in patients with impaired glucose tolerance

Description:

Insulin resistance, hepatocellular lipids (HCL) and plasma concentrations of free fatty acids (FFA) are predictors of heart failure, the leading cause of mortality in patients suffering from type 2 diabetes mellitus (T2DM). Epidemiological data suggest that diabetic cardiomyopathy (DC) presents as ventricular dysfunction in patients with T2DM independent of coronary artery disease. The underlying cellular mechanisms are poorly understood. Reduced mitochondrial activity and insulin resistance of skeletal muscle relates to liver steatosis, possibly due to higher substrate flux to the liver. High oxidation rates in the liver result in oxidative stress, damage of mitochondria and apoptosis. The investigators hypothesize that (i) HCL and impaired liver energy metabolism correlate with ventricular dysfunction, (ii) impaired glucose uptake and mitochondrial capacity in skeletal muscle relates to enhanced oxidative capacity, oxidative stress and lipid deposition in heart tissue (iii) reduced myocardial oxidative capacity limits recovery of myocardial function in patients with acute heart failure. The investigators aim to assess (i) liver energy metabolism and heart function, (ii) respiration and lipid metabolites in skeletal muscle and heart tissue in humans with advanced heart failure and (iii) the prognostic impact of these factors in humans with acute heart failure. This study will improve the understanding of mechanisms underlying the development of DC and the identification of patients at risk for poor outcome in heart failure.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - age = 20 and =85 years - myocardial biopsy for medical reason Exclusion Criteria: - acute infection - autoimmune disease - pregnancy - cancer

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany German Diabetes Center Düsseldorf NRW

Sponsors (2)
Lead Sponsor Collaborator
German Diabetes Center Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary mitochondrial oxygen flux measured using high resolution respirometry. Unit: pmol/(s*mg) Up to 36 months
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