Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia

NCT ID: NCT05937841

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2026-06-01

Brief Summary

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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. 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. The purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage caused by reduced endothelial function in women who have had preeclampsia compared to women who had a healthy pregnancy. Identification of these mechanisms and treatment strategies may lead to better clinical management of cardiovascular disease risk in these women.

The purpose of this study is to examine the microvascular differences in women who have had preeclampsia following activation of protective angiotensin receptors in the skin. This will help increase understanding of the mechanisms of angiotensin II receptors in these women, and how activation of these receptors may restore microvascular function.

In this study, the investigators 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) the investigators examine the blood vessels in a dime-sized area of the skin.

Detailed Description

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Conditions

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Preeclampsia Postpartum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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assessment of microvascular function

The investigators use intradermal microdialysis to deliver compound 21 and L-NAME to the cutaneous microvasculature

Group Type EXPERIMENTAL

Compound 21

Intervention Type DRUG

AT2R sensitivity: compound 21, and compound 21+ L-NAME (nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess AT2R-mediated dilation and role of nitric oxide in this response

Local heating: compound 21 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

Interventions

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Compound 21

AT2R sensitivity: compound 21, and compound 21+ L-NAME (nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess AT2R-mediated dilation and role of nitric oxide in this response

Local heating: compound 21 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

Intervention Type DRUG

Eligibility Criteria

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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
* skin diseases
* current tobacco use
* current antihypertensive medication
* statin or other cholesterol-lowering medication
* currently pregnant or planning to become 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Anna Stanhewicz, PhD

OTHER

Sponsor Role lead

Responsible Party

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Anna Stanhewicz, PhD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anna Reid-Stanhewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kelsey Schwartz

Role: CONTACT

319-467-3096

Facility Contacts

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Kelsey Schwartz

Role: primary

319-467-3096

References

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Schwartz KS, Sun M, Jalal DI, Santillan MK, Stanhewicz AE. Reduced AT2R Signaling Contributes to Endothelial Dysfunction After Preeclampsia. Hypertension. 2025 May;82(5):904-913. doi: 10.1161/HYPERTENSIONAHA.124.24098. Epub 2024 Dec 26.

Reference Type DERIVED
PMID: 39723536 (View on PubMed)

Other Identifiers

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202303202

Identifier Type: -

Identifier Source: org_study_id

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