Purpose

Women who develop preeclampsia during pregnancy are more likely to develop and die of 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 determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin II receptors (losartan) decrease these negative effects in women who have had preeclampsia. Identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women. In this study we use the blood vessels in the skin as a representative vascular bed. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. We make these measurements after the subjects take a placebo and after they take losartan (an angiotensin II receptor blocker) to test whether this treatment improves vascular function in these women. As a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.

Condition

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

Post-partum women, - 18 years or older, - who have delivered within 24 months of the study visit - who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for preeclampsia. [This information will be self-reported by the subjects.] - Using an effective method of birth control and not planning to become pregnant in the next 6 months.

Exclusion Criteria

  • skin diseases, - current tobacco use, - diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2, - statin or other cholesterol-lowering medication, - current antihypertensive medication, - history of hypertension prior to pregnancy, - history of gestational diabetes, - current pregnancy or breastfeeding, - body mass index <18.5 kg/m2, - allergy to materials used during the experiment.(e.g. latex), - known allergies to study drugs.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Losartan
6 weeks of daily (50mg/day) oral losartan potassium tablet
  • Drug: Losartan Potassium
    subjects ingest 50mg losartan potassium tablet daily for 6 weeks
Placebo Comparator
Placebo
6 weeks of daily oral placebo tablet
  • Drug: Placebo
    subjects ingest placebo tablet daily for 6 weeks

Recruiting Locations

University of Iowa
Iowa City, Iowa 52242
Contact:
Anna Stanhewicz, PhD
319-467-1732
anna-stanhewicz@uiowa.edu

More Details

NCT ID
NCT04632589
Status
Recruiting
Sponsor
Anna Stanhewicz, PhD

Study Contact

Anna Stanhewicz, PhD
319-467-1732
anna-stanhewicz@uiowa.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.