Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

Preeclampsia Clinical Trial

Official title:

Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03482440
• Other study ID #: HL138133
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 26, 2018
• Est. completion date: March 2023

Study information

• Verified date: May 2022
• Source: University of Iowa
• Contact: Anna Stanhewicz, PhD
• Phone: 319-467-1732
• Email: anna-stanhewicz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Salsalate Oral Tablet
1500mg twice daily for 5 days prior to experimental testing
• Placebo Oral Tablet
Placebo oral table twice daily for 5 days prior to experimental testing

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in endothelial function following salsalate treatment compared to placebo treatment	Endothelium-dependent vasodilation assessed by reactivity to exogenous acetylcholine	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
Secondary	change in inflammatory response to ang II compared to baseline	inflammatory cytokine release by isolated peripheral blood mononuclear cells	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