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Trial record 2 of 112 for:    EPLERENONE

Eplerenone and Extracellular Adenosine Formation (eplerenone01)

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ClinicalTrials.gov Identifier: NCT01837108
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE April 12, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date January 9, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01837108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 17, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Eplerenone and Extracellular Adenosine Formation
Official Title  ICMJE Effects of the Selective Mineralocorticoid Receptor Antagonist Eplerenone on Extracellular Adenosine Formation in Humans in Vivo
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacodynamics
Intervention  ICMJE
  • 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
    Other Name: Inspra, RVG 29963
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    fully mimicking placebo 50 mg bid during 8 days
    Intervention: Drug: Placebo
  • Experimental: eplerenone
    eplerenone 50 mg bid during 8 days
    Intervention: Drug: Eplerenone
Publications * van den Berg TN, Deinum J, Bilos A, Donders AR, Rongen GA, Riksen NP. The effect of eplerenone on adenosine formation in humans in vivo: a double-blinded randomised controlled study. PLoS One. 2014 Oct 30;9(10):e111248. doi: 10.1371/journal.pone.0111248. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2013)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837108
Other Study ID Numbers  ICMJE NL43234.091.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Niels Riksen, Dr. Radboud University Medical Centre Nijmegen
Study Chair: Gerard Rongen, Prof. Radboud University Medical Centre Nijmegen
PRS Account Radboud University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP