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NCT Number: NCT06749418

Vascular Effects of High-Salt After Preeclampsia

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

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.

Primary outcomes

  1. 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)

    Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of eplerenone compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response

  2. Changes in 24-hour urine sodium

    Time frame: Day 2, Day 9

    The investigators will measure urine sodium to ensure differences in salt-take between low- and high-salt.

Secondary outcomes

  1. Changes in circulating aldosterone concentrations

    Time frame: Day 3, Day 10

    The investigators will collect blood at the start of each experiment to determine differences in aldosterone concentrations between low- and high-salt.

  2. Changes in circulating angiotensin II concentrations

    Time frame: Day 3, Day 10

    The investigators will collect blood at the start of each experiment to determine differences in circulating angiotensin II concentrations between low- and high-salt.

  3. Changes in ambulatory blood pressure

    Time frame: Day 2, Day 9

    The investigators will measure ambulatory blood pressure, assessed as mean arterial pressure calculated from measured systolic and diastolic pressures, responses to low- and high-salt.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Schwartz, PhD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Official study title

Role of the Mineralocorticoid Receptor in Microvascular Endothelial Dysfunction After Preeclampsia

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 27, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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