MR and Inflammation After Preeclampsia

Anna Stanhewicz, PhD

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Preeclampsia; Preeclampsia Postpartum

Treatments: Drug: Eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT07345845

202508378

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Assessment of microvascular function

Experimental group

Description:

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

Treatment:

Drug: Eplerenone