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Completed

NCT Number: NCT04632589

Losartan for Improved Vascular Endothelial Function After Preeclampsia

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.

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Key information

Conditions

Preeclampsia Postpartum

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan Potassium

Drug

subjects ingest 50mg losartan potassium tablet daily for 6 weeks

Placebo

Drug

subjects ingest placebo tablet daily for 6 weeks

Primary outcomes

  1. Cutaneous Conductance (%Maximum) Response to Acetylcholine

    Time frame: immediately following 6 weeks of oral treatment (losartan or placebo)

    Cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry during intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site specific maximal dilation (%maximum).

  2. Cutaneous Conductance (%Baseline) Response to Angiotensin II

    Time frame: immediately following 6 weeks of oral treatment (losartan or placebo)

    Cutaneous vascular constrictor response to exogenous ang II perfusion; measured by laser-Doppler flowmetry during intradermal microdialysis delivery of angiotensin II. Cutaneous conductance is calculated (laser-Doppler flux/mean arterial pressure) and normalized to site-specific baseline conductance (%baseline) measured on the study day before the perfusion of angiotensin II.

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Official study title

Angiotensin II Receptor Inhibition to Improve Microvascular Function in Women Who Have Had Preeclampsia

Acronym: LIVE-PE

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Nov 17, 2020
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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