Balance of Angiotensin II Receptors in Vessel Function After Preeclampsia

NCT ID: NCT06157580

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2024-12-10

Brief Summary

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.

Conditions

Preeclampsia

Keywords

postpartum; vascular

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

History of a preeclampsia

Women who had preeclampsia in their most recent pregnancy

Group Type: OTHER

Compound 21

Intervention Type: DRUG

differences in vasodilation to compound 21 in the skin between groups

Angiotensin II

Intervention Type: DRUG

differences in vasoconstriction to angiotensin II in the skin between groups

History of a healthy pregnancy

Women who had an uncomplicated pregnancy

Group Type: OTHER

Compound 21

Intervention Type: DRUG

differences in vasodilation to compound 21 in the skin between groups

Angiotensin II

Intervention Type: DRUG

differences in vasoconstriction to angiotensin II in the skin between groups

Interventions

Compound 21

differences in vasodilation to compound 21 in the skin between groups

Intervention Type: DRUG

Angiotensin II

differences in vasoconstriction to angiotensin II in the skin between groups

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Anna Stanhewicz, PhD

OTHER

Sponsor Role: lead

Responsible Party

Anna Stanhewicz, PhD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202309383

Identifier Type: -

Identifier Source: org_study_id