Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preecla… (NCT03482440) | Clinical Trial Compass
CompletedEarly Phase 1
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia
United States24 participantsStarted 2018-08-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
Timeframe: immediately following the 4 days or oral treatment (salsalate or placebo)