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Completed

NCT Number: NCT01837108

Eplerenone and Extracellular Adenosine Formation

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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Key information

Conditions

Pharmacodynamics

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Medical Centre

Nijmegen, Gelderland, 6525EZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

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

Other names: Inspra, RVG 29963

Placebo

Drug

Primary outcomes

  1. forearm blood flow response

    Time frame: 8 days

    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.

Secondary outcomes

  1. forearm blood flow

    Time frame: 8 days

    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.

  2. forearm blood flow

    Time frame: 8 days

    Forearm blood flow to incremental periods of arterial occlusion. The forearm blood flow will be measured by plethysmography.

Other outcomes

  1. 24 hours urine sample

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Effects of the Selective Mineralocorticoid Receptor Antagonist Eplerenone on Extracellular Adenosine Formation in Humans in Vivo

Acronym: eplerenone01

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Apr 22, 2013
Registry last updated
Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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