Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

Anna Stanhewicz, PhD

Status and phase: Completed; Early Phase 1

Conditions: Preeclampsia

Treatments: Drug: Angiotensin II; Drug: Compound 21

Study type: Interventional

Funder types: Other

Identifiers

NCT06157580

202309383

Details and patient eligibility

About

Otherwise healthy women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life. The reason why this occurs is unclear but may be related to impaired endothelial function and dysregulation of the angiotensin system that occurs during preeclampsia 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 differences in the microvascular balance of angiotensin II receptors women who have had preeclampsia. This will help the investigators better understand the mechanisms of dysregulated angiotensin II receptors in formerly preeclamptic women, and how activation or inhibition 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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 or gestational hypertension
• 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 or >30 kg/m2
• allergy to materials used during the experiment.(e.g. latex),
• known allergy to study drugs

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

History of a preeclampsia

Other group

Description:

Women who had preeclampsia in their most recent pregnancy

Treatment:

Drug: Compound 21

Drug: Angiotensin II

History of a healthy pregnancy

Other group

Description:

Women who had an uncomplicated pregnancy

Treatment:

Drug: Compound 21

Drug: Angiotensin II