Effect of Eplerenone on Endothelial Function in Metabolic Syndrome (MetSyn)
Patients with the metabolic syndrome (MetSyn) are at increased risk for cardiovascular mortality and morbidity.This increased cardiovascular risk is attributed to metabolic dysregulations like impaired glucose tolerance or diabetes mellitus and dyslipidemia, abdominal obesity and arterial hypertension, which promote oxidative stress and inflammation with consecutive endothelial dysfunction causing an atherogenic environment.
Aldosterone promoted end organ damage is mainly found in the cardiovascular system and the kidney. Inflammation and activation of different factors promotes fibroblast growth and matrix production resulting in myocardial fibrosis, vascular remodelling and renal fibrosis.
MetSyn and aldosterone are cardiovascular risk factors and it is of crucial importance to note that there is a connection between MetSyn and aldosterone. Other cross sectional studies show a direct correlation of aldosterone levels and impaired glucose metabolism in patients with and without the MetSyn. Taken together, aldosterone influences essential parameters of the MetSyn. Coincidentally parameters of the MetSyn are stimulus for an increased aldosterone synthesis, i.e. visceral adipocytes.
In large scale clinical trials - RALES, EPHESUS, 4E - inhibition of MR has proven to be beneficial in patients with congestive heart failure and post myocardial infarction and this result has been confirmed for diabetic patients, who are known to have an increased cardiovascular risk.
There is only very limited data on the impact of MR inhibition on metabolic, endocrine, and inflammatory parameters in patients with MetSyn, who have not yet suffered from cardiovascular events.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prospective and Open Label Study With Blind End Point Evaluation on the Effect of Mineralocorticoid Receptor Inhibition on Endothelial Function of the Micro- and Macrovasculature in Patients With Metabolic Syndrome|
- Change of basal nitric oxide activity as assessed by change of retinal capillary flow (measured by Scanning Laser Doppler Flowmetry) [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
- Changes of distensibility of the carotid artery. [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
- Change of flow mediated dilation of the brachial artery. [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
25 mg o.d. per os
Other Name: Inspra
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|Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg|
|Erlangen, Germany, 91054|
|Clinical Research Unit, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg|
|Nürnberg, Germany, 90471|
|Principal Investigator:||Roland E Schmieder, Prof||University of Erlangen-Nurnberg|