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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05937841
Other study ID # 202303202
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 28, 2023
Est. completion date June 1, 2025

Study information

Verified date July 2023
Source University of Iowa
Contact Kelsey Schwartz
Phone 319-467-3096
Email kelsey-schwartz@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Anna Stanhewicz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry Cutaneous vascular vasodilator response (cutaneous conductance; %max) to exogenous compound 21 perfusion; intradermal microdialysis for the local delivery of compound 21 post 1 hour of skin perfusion
Primary Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry 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 post 1 hour of skin perfusion
Secondary Angiotensin receptor expression in endothelial cells Quantify expression of angiotensin II receptor expression in biopsied endothelial cells a total of 1 time during the study, within ~4 weeks following enrollment
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