Recruiting
Early Phase 1

Observational Study

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT06749418

Conditions

Preeclampsia

Preeclampsia Postpartum

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Eplerenone

Study Details

Brief summary:

Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. Importantly, women who had preeclampsia have an exaggerated vascular responsiveness to hypertensive stimuli, such as high-salt intake, compared to women who had a healthy pregnancy. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during the preeclamptic pregnancy and persists postpartum, despite the remission of clinical symptoms. While the association between a history of preeclampsia and vascular dysfunction leading to elevated CVD risk is well known, the mechanisms underlying this dysfunction remains unclear.

The purpose of this study is to examine the role of vascular mineralocorticoid receptor, the terminal receptor in the angiotensin system that contributes to blood pressure regulation, in mediating exaggerated microvascular endothelial dysfunction before and after a high-salt stimulus. This will help us better understand the mechanisms of microvascular dysfunction these women, and how inhibition of these receptors may improve microvascular function.

In this study, we use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickel-sized area of the skin.

Conditions

Preeclampsia

Preeclampsia Postpartum

Study ID

NCT06749418

Start date

Jan 2, 2025

Status verified date

Feb, 2026

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: High-salt supplement

Participants will be counseled to consume a low-salt diet (<2000 mg/day of sodium) for 10 days. After 3 days of a low-salt diet, participants will consume the high-salt supplement (4500 mg/day) for 7 days while maintaining a low-salt diet. On days 3 and 10, participants will arrive at the laboratory where the investigators will assess microvascular endothelial function. Blood will be collected to investigate circulating angiotensin II responses to low- (day 3) and high- (day 10) salt diet. On days 2 and 9, participants will undergo ambulatory blood pressure monitoring and 24-hour urine collection.

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.

Primary outcome measure

  • Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry [ Time Frame: Day 3 (low-salt diet run in) and Day 10 (low-salt diet + high-salt supplement) ]
  • Changes in 24-hour urine sodium [ Time Frame: Day 2, Day 9 ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Principal Investigator:

Anna Reid-Stanhewicz, PhD

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2026-02-13.