A Phase 4 interventional study of Eplerenone and Placebo in Pharmacodynamics, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-09.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Basic science
Various studies have reported cardioprotective effects of mineralocorticoid receptor (MR) antagonists in the setting of an acute myocardial infarction. In a recent animal study, the protective effect of MR antagonists on infarct size was completely abolished in CD73 knock-out and adenosine A2b receptor knock-out mice, and by co-administration of adenosine receptor antagonists in rats. These findings suggest that extracellular formation of adenosine is crucial for this protective effect and that MR antagonists stimulate extracellular adenosine formation by the enzyme CD73.
To investigate whether eplerenone promotes adenosine receptor stimulation by activating CD73, the investigators will measure forearm blood flow in response to various dosages of dipyridamole with the use of plethysmography. Dipyridamole increases the extracellular endogenous adenosine concentration by inhibition of the ENT transporter and induces local vasodilation. Therefore, the vasodilator effect of dipyridamole accurately reflects extracellular adenosine formation by the CD73 enzyme.
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fully mimicking placebo 50 mg bid during 8 days
Drug: Placebo
eplerenone 50 mg bid during 8 days
Drug: Eplerenone
2 tabs of eplerenone 25 mg will be over-encapsulated and a fully mimicking placebo will be provided by the department of clinical pharmacy of the Radboud University Medical Centre Nijmegen
Also known as: Inspra, RVG 29963
forearm blood flow response
Forearm blood flow response to the intrabrachial administration of incremental dosages of dipyridamole, after treatment with eplerenone, compared to placebo. The forearm blood flow will be measured by plethysmography.
Time frame: 8 days
forearm blood flow
Forearm blood flow response to the intrabrachial administration of incremental dosages of dipyridamole, with and without caffeine, after eplerenone treatment. The forearm blood flow will be measured by plethysmography.
Time frame: 8 days
forearm blood flow
Forearm blood flow to incremental periods of arterial occlusion. The forearm blood flow will be measured by plethysmography.
Time frame: 8 days
24 hours urine sample
Twenty-four hours urine samples will be collected and sodium and creatinine will be determined, to ensure that salt intake is approximately the same during both treatment days.
Time frame: 1 day
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center