Eplerenone for Preeclampsia

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Anna Stanhewicz, PhD

Must not be taking: Antihypertensives, Statins

Disqualifiers: Hypertension, Metabolic disease, Gestational diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Anna Reid-Stanhewicz, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 who experienced preeclampsia, as well as those who did not, provided they are between 12 weeks to 5 years postpartum. It aims to understand the role of a specific receptor in blood vessel function and inflammation after preeclampsia.

Inclusion Criteria

I have had preeclampsia/I have not had preeclampsia.

I am between 18 and 45 years old.

I gave birth between 12 weeks and 5 years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Visits

Participants undergo two experimental visits to assess microvascular function and collect endothelial cells

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental visits

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eplerenone

Trial Overview

The study tests Eplerenone's effect on endothelial function and inflammation in women with past preeclampsia. It involves two lab visits: one for measuring skin blood flow and another for collecting endothelial cells from a vein.

How Is the Trial Designed?

Group I: Assessment of microvascular function Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Anna Stanhewicz, PhD

Lead Sponsor

Trials

12

Recruited

460+