Clinical trial NCT05937841: Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Official title: Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Preeclampsia Postpartum
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 30
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. 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.


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

Primary outcomes:
measure: Change in microvascular blood flow response to local compound 21 treatment measured by laser-Doppler flowmetry
timeFrame: post 1 hour of skin perfusion
measure: Change in microvascular endothelial function following local C21 treatment compared to placebo treatment measured by laser-Doppler flowmetry
timeFrame: post 1 hour of skin perfusion
Secondary outcomes:
measure: Angiotensin receptor expression in endothelial cells
timeFrame: a total of 1 time during the study, within ~4 weeks following enrollment
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: