Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

NCT03482440 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 201909818
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

preeclampsia; microvascular; inflammation; angiotensin II

Outcome Measures

Primary Outcomes (1)

• Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)

  Endothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to exogenous acetylcholine delivered via intradermal microdialysis.

  immediately following the 4 days or oral treatment (salsalate or placebo)

Secondary Outcomes (1)

• Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II

  at the completion of 4 days of oral (placebo or salsalate) treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Salsalate

EXPERIMENTAL

Drug: Salsalate Oral Tablet

Interventions

Salsalate Oral Tablet DRUG

1500mg twice daily for 4 days prior to experimental testing

Salsalate

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years and older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead
• Penn State University: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Inflammation

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anna Stanhewicz
• Organization: University of Iowa

anna-stanhewicz@uiowa.edu

3194671732

Study Officials

• Anna Stanhewicz, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 29, 2018
• Study Start: August 26, 2018
• Primary Completion: July 11, 2019
• Study Completion: December 31, 2022
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)