Clinical trial NCT06749418: Vascular Effects of High-Salt After Preeclampsia
Official title: Role of the Mineralocorticoid Receptor in Microvascular Endothelial Dysfunction After Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Preeclampsia
Preeclampsia Postpartum
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in microvascular endothelial function following local eplerenone treatment compared to placebo treatment measured by laser-Doppler flowmetry
timeFrame: Day 3 (low-salt diet run in) and Day 10 (low-salt diet + high-salt supplement)
measure: Changes in 24-hour urine sodium
timeFrame: Day 2, Day 9
Secondary outcomes:
measure: Changes in circulating aldosterone concentrations
timeFrame: Day 3, Day 10
measure: Changes in circulating angiotensin II concentrations
timeFrame: Day 3, Day 10
measure: Changes in ambulatory blood pressure
timeFrame: Day 2, Day 9
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Anna Reid-Stanhewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: