Primary Hyperaldosteronism and Ischemia-reperfusion Injury

Not Applicable

Completed

• Conditions: Primary Hyperaldosteronism
• Interventions: Procedure: forearm ischemia and reperfusion

• Registration Number: NCT01978132
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level.

In this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.

Detailed Description

Patients with PHA have an increased risk of cardiovascular events, independent of blood pressure level. Also in patients suffering a myocardial infarction, circulating aldosterone levels are associated with increased mortality. In animal models of myocardial infarction, the administration of exogenous aldosterone increased infarct size, although other studies did not report this effect. In similar models, antagonists of the mineralocorticoid receptor (MR) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (CD73, the enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and adenosine receptor knock-out mice. Therefore, we hypothesize that patients with PHA have an increased susceptibility for ischemia-reperfusion (IR)-injury due to down-regulation of the enzyme CD73. We will use the reduction in brachial flow-mediated dilation (FMD) by forearm IR as a well-validated endpoint for (endothelial) IR-injury.

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-07
• Status Verified: 2017-04
• Primary Completion: 2017-05-01
• Study Completion: 2017-07-01
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary hyperaldosteronism	forearm ischemia and reperfusion	patients with primary hyperaldosteronism will be subjected to the intervention forearm ischemia and reperfusion (20 minutes of forearm ischemia and 20 minutes of reperfusion). Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury
Primary hypertension	forearm ischemia and reperfusion	Patients with primary hypertension (PHA excluded)will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion. Primary endpoint is the reduction in brachial FMD by forearm ischemia-reperfusion, as a measure of endothelial ischemia-reperfusion injury

Primary Outcome Measures

Name	Time	Method
brachial FMD	1 day morning	primary outcome measure is the reduction in brachial artery FMD after 20 minutes of forearm ischemia and 20 minutes of reperfusion in patients with primary hyperaldosteronism (compared to patients with primary hypertension)

Secondary Outcome Measures

Name	Time	Method
CD73 and adenosine	one day morning (just before FMD experiment)	Blood will be drawn to determine circulating adenosine concentration and the CD73 activity on mononuclear cells

Trial Locations

Locations (1)

Radboud University Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands