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?

This trial explores whether eplerenone, a mineralocorticoid receptor antagonist, can address blood vessel problems in women who experienced preeclampsia, a condition characterized by high blood pressure during pregnancy. Researchers aim to determine if mineralocorticoid receptors contribute to blood flow and inflammation issues. Women who had preeclampsia between 12 weeks and 5 years after childbirth may qualify for this trial. Participants will attend two lab visits to measure blood flow and collect cell samples. As an Early Phase 1 trial, this research focuses on understanding how eplerenone works in people, offering participants a chance to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

If you are currently taking antihypertensive or cholesterol-lowering medications, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that eplerenone is likely to be safe for humans?

Research has shown that eplerenone is usually safe, even for pregnant women. One study found no harm to babies when pregnant women used it. However, another study found that people taking eplerenone experienced more side effects than those taking a placebo, a harmless pill. This suggests some risks may exist, but it has been used safely in certain cases. Prospective trial participants should consider these findings and discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about eplerenone for preeclampsia because it offers a potentially new way to manage this condition by targeting the microvasculature. Unlike standard treatments, which often focus on managing symptoms like high blood pressure without directly affecting the underlying vascular issues, eplerenone is delivered directly to the cutaneous microvasculature using intradermal microdialysis. This unique delivery method allows for a more localized effect, which could lead to better outcomes by improving microvascular function and reducing the complications associated with preeclampsia.

What evidence suggests that eplerenone might be an effective treatment for preeclampsia?

Research shows that eplerenone, initially used for high blood pressure, might improve blood vessel health in women who had preeclampsia. Studies in mice indicate that eplerenone can lower high blood pressure related to preeclampsia and may reduce the harmful effects of certain hormones on blood vessels. Although research in humans remains limited, these early findings suggest that eplerenone could benefit the blood vessel health of women who experienced preeclampsia. Participants in this trial will receive eplerenone to assess its effects on microvascular function. ^{2 6 7 8 9}

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41533341/

Eplerenone lowers maternal blood pressure in a model of ...

Eplerenone lowers maternal blood pressure in a model of leptin-induced preeclampsia, but decreases fetal growth when administered mid-, but not ...

2.

nature.com

nature.com/articles/s41598-025-02475-0

Postpartum administration of eplerenone to mitigate ...

In this study, we modelled preeclampsia in the mouse via nitric oxide blockade and examined the effect of therapeutic intervention during ...

3.

withpower.com

withpower.com/trial/early-phase-1-pre-eclampsia-2025-20014

Eplerenone for Preeclampsia

This trial explores how the drug Eplerenone might improve blood vessel function in women who experienced preeclampsia during pregnancy.

4.

researchgate.net

researchgate.net/publication/399775806_Eplerenone_lowers_maternal_blood_pressure_in_a_model_of_leptin-induced_preeclampsia_but_decreases_fetal_growth_when_administered_mid-_but_not_late-_gestation

Eplerenone lowers maternal blood pressure in a model of ...

In conclusion, our data suggest that although eplerenone improves leptin-induced hypertension in pregnant mice, eplerenone reduces fetal weight ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2025/021437s018lbl.pdf

Reference ID: 5608959 - accessdata.fda.gov

The available data from published case reports on eplerenone use during pregnancy are insufficient to establish a drug-associated risk of major birth defects, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12116800/

Postpartum administration of eplerenone to mitigate ...

Postpartum eplerenone treatment may be beneficial in mitigating consequent cardiovascular disease risk following a pregnancy complicated by preeclampsia.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167527314018117

Efficacy and safety of eplerenone in the management ...

Rates of any adverse event were significantly higher with eplerenone than placebo (odds ratio 1.37, 95% CI 1.1 to 1.71; p = 0.005), whereas the ...

8.

link.springer.com

link.springer.com/article/10.1007/s11154-022-09729-6

Primary aldosteronism in pregnancy - Springer Link

On the other side, eplerenone, has proven to be safe and effective in 6 pregnant women and may be added to conventional first line drug regimen ...

9.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.18858

Management and Outcomes of Primary Aldosteronism in ...

Results showed that complications involved 62.2% of pregnant women with nonfamilial PA and 18.5% of those with familial hyperaldosteronism type ...