MR and Inflammation After Preeclampsia

Contribution of Mineralocorticoid Receptor Signaling to Vascular Dysfunction & Aberrant Inflammation After Preeclampsia

The purpose of this investigation is to examine the role of inappropriate mineralocorticoid receptor activation in endothelial dysfunction and vascular inflammation in otherwise healthy women with a history of preeclampsia. The main questions it aims to answer are:

1. Does overactivation of the mineralocorticoid receptor contribute to reduced endothelial function in women who had preeclampsia?
2. To what extent does the mineralocorticoid receptor mediated exaggerated production of inflammatory cytokines in immune cells from women who had preeclampsia?

Participants will visit the research laboratory for 2 experimental visits:

• Visit 1: Skin blood flow will be measured using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) to examine blood vessels in a nickel-sized area of the skin.
• Visit 2: Endothelial cells will be collected from an antecubital vein.

Study Overview

• Status: Active, not recruiting
• Conditions: Preeclampsia; Preeclampsia Postpartum
• Intervention / Treatment: Drug: Eplerenone

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• women who had preeclampsia and women who did not have preeclampsia
• 12 weeks to 5 years postpartum
• 18-45 years old

Exclusion Criteria:

• history of hypertension or metabolic disease before pregnancy
• history of gestational diabetes
• history of gestational hypertension without preeclampsia
• skin diseases
• current tobacco use
• current antihypertensive medication
• statin or other cholesterol-lowering medication
• currently pregnant
• body mass index less than 18.5 kg/m2
• allergy to materials used during the experiment.(e.g. latex),
• known allergy to study drugs or salt-supplement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assessment of microvascular function; The investigators use intradermal microdialysis to deliver eplerenone and L-NAME to the cutaneous microvasculature	Drug: Eplerenone; Local heating: eplerenone is locally and acutely delivered to the cutaneous microvasculature during local heating of the skin to assess endothelium-dependent dilation, L-NAME is added to assess nitric oxide-dependent dilation during this response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry	Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of eplerenone compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response	post 1 hour of skin perfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mineralocorticoid receptor expression in endothelial cells	The investigators will quantify expression of the mineralocorticoid receptor in biopsied endothelial cells.	a total of 1 time during the study, within ~4 weeks following enrollment
Inflammatory response from isolated immune cells	The investigators will measure inflammatory responses, assessed as inflammatory cytokine release following activation of immune cells in the presence and absence of eplerenone treatment. Cells are collected from a blood draw and treated with eplerenone in a cell culture environment (ex vivo treatment).	from a blood draw collected at the start of the experimental visit

Collaborators and Investigators

• Sponsor: Anna Stanhewicz, PhD
• Investigators: Principal Investigator: Anna Reid-Stanhewicz, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Organic Chemicals; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Pregnenes; Eplerenone
• Other Study ID Numbers: 202508378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No