Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

Early Phase 1

• Conditions: Preeclampsia
• Interventions: Drug: Placebo Oral Tablet; Drug: Salsalate Oral Tablet

• Registration Number: NCT03482440
• Lead Sponsor: University of Iowa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Study Start: 2018-08-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	-
Salsalate	Salsalate Oral Tablet	-

Primary Outcome Measures

Name	Time	Method
change in endothelial function following salsalate treatment compared to placebo treatment	a total of 2 times throughout the study (approximately 4 weeks): 1) at the completion of 5 days of oral salsalate treatment, and 2) at the completion of 5 days of placebo treatment	Endothelium-dependent vasodilation assessed by reactivity to exogenous acetylcholine

Secondary Outcome Measures

Name	Time	Method
change in inflammatory response to ang II compared to baseline	a total of 3 times throughout the study (approximately 4 weeks): 1) at the beginning of the study, 2) at the completion of the 5 day placebo treatment, and 3) at the completion of 5 days of oral salsalate treatment	inflammatory cytokine release by isolated peripheral blood mononuclear cells

Trial Locations

Locations (2)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States