Eplerenone and Extracellular Adenosine Formation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

fully mimicking placebo 50 mg bid during 8 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

eplerenone

eplerenone 50 mg bid during 8 days

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Inspra, RVG 29963

Eligibility Criteria

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Inclusion Criteria

* Male sex
* Age 18-40 years
* Healthy
* Written informed consent

Exclusion Criteria

* Smoking
* Hypertension (Blood pressure \>140 mmHg and/or \>90 mmHg - SBP/DBP-)
* Hypotension (Blood pressure \<100 mmHg and/or \<60 mmHg -SBP/DBP-)
* Diabetes Mellitus (fasting glucose \> 6.9 mmol/L or random \> 11.0 mmol/L in venous plasma)
* History of any cardiovascular disease
* Angina pectoris
* History of chronic obstructive pulmonary disease (COPD) or asthma
* Alcohol and/or drug abuse
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min/1.73 m2)
* Liver enzyme abnormalities (ALAT \> twice upper limit of normality)
* Serum potassium ≥ 4.8 mmol/L
* Fasting total cholesterol \> 6.0 mmol/L
* Second/third degree AV-block on electrocardiography

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes