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Not recruiting
Early Phase 1

Losartan

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT04632589

Conditions

Preeclampsia Postpartum

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Losartan Potassium

Placebo

Study Details

Brief summary:

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.

Conditions

Preeclampsia Postpartum

Study ID

NCT04632589

Start date

Nov 22, 2020

Status verified date

Aug, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jun 30, 2024

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Losartan

6 weeks of daily (50mg/day) oral losartan potassium tablet

placebo comparator: Placebo

6 weeks of daily oral placebo tablet

Interventions

Losartan Potassium

subjects ingest 50mg losartan potassium tablet daily for 6 weeks

Placebo

subjects ingest placebo tablet daily for 6 weeks

Primary outcome measure

  • Microvascular endothelial function following systemic AT1 receptor inhibition [ Time Frame: at the completion of 6 weeks of oral losartan treatment ]
  • Microvascular endothelial function following placebo [ Time Frame: at the completion of 6 weeks of placebo treatment ]
  • Microvascular angiotensin II sensitivity following systemic AT1 receptor inhibition [ Time Frame: at the completion of 6 weeks of oral losartan treatment, and 2) at the completion of 6 weeks of placebo treatment ]
  • Microvascular angiotensin II sensitivity following placebo [ Time Frame: at the completion of 6 weeks of placebo treatment ]
  • Central and Peripheral Vascular Stiffness following systemic AT1 receptor inhibition [ Time Frame: at the completion of 6 weeks of oral losartan treatment ]
  • Central and Peripheral Vascular Stiffness following placebo [ Time Frame: at the completion of 6 weeks of placebo treatment ]

Central Contacts and Locations

Central contacts

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2024-08-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.