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NCT Number: NCT05937841

Sensitivity of Angiotensin II Type II Receptors in Women Following 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. 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Kelsey Schwartz

CONTACT

[email protected]

319-467-3096

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
  • 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

Treatment and study plan

Compound 21

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

Primary outcomes

  1. Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry

    Time frame: post 1 hour of skin perfusion

    Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21

  2. Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry

    Time frame: post 1 hour of skin perfusion

    Cutaneous vascular vasodilator response (cutaneous conductance; %max) to local heating of the skin; intradermal microdialysis for the local delivery of compound 21 compared to control (Ringer's solution), followed by L-NAME infusion to quantify NO-dependent response

Secondary outcomes

  1. Angiotensin receptor expression in endothelial cells

    Time frame: a total of 1 time during the study, within ~4 weeks following enrollment

    Quantify expression of angiotensin II receptor expression in biopsied endothelial cells

Study contacts

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

Kelsey Schwartz

CONTACT

[email protected]

319-467-3096

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2023
Registry last updated
Aug 24, 2025

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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