MR and Inflammation After Preeclampsia

NCT ID: NCT07345845

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2029-02-01

Brief Summary

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.

Conditions

Preeclampsia; Preeclampsia Postpartum

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Assessment of microvascular function

The investigators use intradermal microdialysis to deliver eplerenone and L-NAME to the cutaneous microvasculature

Group Type: EXPERIMENTAL

Eplerenone

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anna Stanhewicz, PhD

OTHER

Sponsor Role: lead

Responsible Party

Anna Stanhewicz, PhD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anna Reid-Stanhewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202508378

Identifier Type: -

Identifier Source: org_study_id