Clinical trial NCT03482440: Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
Official title: Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Preeclampsia
Keywords: preeclampsia
microvascular
inflammation
angiotensin II
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2018-03-29
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
timeFrame: immediately following the 4 days or oral treatment (salsalate or placebo)
Secondary outcomes:
measure: Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II
timeFrame: at the completion of 4 days of oral (placebo or salsalate) treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: University of Iowa
name: Anna Stanhewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: