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NCT Number: NCT07345845

MR and 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Preeclampsia Postpartum Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Eplerenone

Drug

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

Primary outcomes

  1. Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry

    Time frame: post 1 hour of skin perfusion

    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

Secondary outcomes

  1. Mineralocorticoid receptor expression in endothelial cells

    Time frame: a total of 1 time during the study, within ~4 weeks following enrollment

    The investigators will quantify expression of the mineralocorticoid receptor in biopsied endothelial cells.

  2. Inflammatory response from isolated immune cells

    Time frame: from a blood draw collected at the start of the experimental visit

    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).

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

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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