Back to resultsAngiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
Primary Purpose
Preeclampsia
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Salsalate Oral Tablet
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional basic science trial for Preeclampsia focused on measuring preeclampsia, microvascular, inflammation, angiotensin II
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.
Sites / Locations
- University of Iowa
- Pennsylvania State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Salsalate
Arm Description
Outcomes
Primary Outcome Measures
change in endothelial function following salsalate treatment compared to placebo treatment
Endothelium-dependent vasodilation assessed by reactivity to exogenous acetylcholine
Secondary Outcome Measures
change in inflammatory response to ang II compared to baseline
inflammatory cytokine release by isolated peripheral blood mononuclear cells
Full Information
NCT ID
NCT03482440
First Posted
March 15, 2018
Last Updated
May 16, 2022
Sponsor
University of Iowa
Collaborators
Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT03482440
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
preeclampsia, microvascular, inflammation, angiotensin II
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Salsalate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Salsalate Oral Tablet
Intervention Description
1500mg twice daily for 5 days prior to experimental testing
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo oral table twice daily for 5 days prior to experimental testing
Primary Outcome Measure Information:
Title
change in endothelial function following salsalate treatment compared to placebo treatment
Description
Endothelium-dependent vasodilation assessed by reactivity to exogenous acetylcholine
Time Frame
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 Outcome Measure Information:
Title
change in inflammatory response to ang II compared to baseline
Description
inflammatory cytokine release by isolated peripheral blood mononuclear cells
Time Frame
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Stanhewicz, PhD
Phone
319-467-1732
Email
anna-stanhewicz@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Stanhewicz, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Stanhewicz, PhD
Phone
319-467-1732
Email
anna-stanhewicz@uiowa.edu
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Slimak, RN
Phone
814-863-8556
Email
sks31@psu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared
Learn more about this trial
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
We'll reach out to this number within 24 hrs