Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

NCT ID: NCT03482440

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-26
• Study Completion Date: 2022-12-31

Brief Summary

Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

Placebo oral table twice daily for 4 days prior to experimental testing

Salsalate

Group Type: EXPERIMENTAL

Salsalate Oral Tablet

Intervention Type: DRUG

1500mg twice daily for 4 days prior to experimental testing

Interventions

Salsalate Oral Tablet

1500mg twice daily for 4 days prior to experimental testing

Intervention Type: DRUG

Placebo Oral Tablet

Placebo oral table twice daily for 4 days prior to experimental testing

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the American College of Obstetricians and Gynecologists criteria for severe preeclampsia. [This information will be self-reported by the subjects.]
• Post-partum women who have delivered within two years and who have had a normal pregnancy.
• 18 years and older.

Exclusion Criteria

• skin diseases
• current tobacco use
• diagnosed or suspected hepatic or metabolic disease
• statin or other cholesterol-lowering medication
• history of hypertension prior to pregnancy
• history of gestational diabetes
• current pregnancy
• allergy to aspirin or NSAIDs or known allergy to materials used during the experiment (e.g. latex)
• renal disease, bleeding disorders and history of gastrointestinal bleeding.
• Known allergies to study drugs
• Taking blood thinners, aspirin or NSAIDS.
• Women who choose to breastfeed will not participate in any parts of the project that include salsalate.

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

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Anna Stanhewicz, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Stanhewicz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

201909818

Identifier Type: -

Identifier Source: org_study_id