Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Compound 21.
- Who it may be relevant to
- Registry conditions: Preeclampsia Postpartum. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug 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
Primary outcome measures
- Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry [Time frame: post 1 hour of skin perfusion]
- 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]
Secondary outcome measures (1)
- Angiotensin receptor expression in endothelial cells [Time frame: a total of 1 time during the study, within ~4 weeks following enrollment]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Publications
- 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. PMID 39723536
Identifiers
NCT: NCT05937841 · 202303202