Early Phase 1
N=23
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
Preeclampsia
Bottom Line
View on ClinicalTrials.gov: NCT03482440 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Microvascular Endothelial Function (Cutaneous Conductance, %Maximum) — 95; 77 % of maximal cutaneous conductance
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Salsalate Oral Tablet (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Iowa
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microvascular Endothelial Function (Cutaneous Conductance, %Maximum) |
95; 77 | — |
| SECONDARY Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II |
2.37; 2.77 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03482440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.