Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

University of Iowa

Status and phase: Completed; Early Phase 1

Conditions: Preeclampsia

Treatments: Drug: Placebo Oral Tablet; Drug: Salsalate Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03482440

201909818

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet

Salsalate

Experimental group

Treatment:

Drug: Salsalate Oral Tablet