Losartan for Improved Vascular Endothelial Function After Preeclampsia

NCT04632589 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: 202006148
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cutaneous Conductance (%Maximum) Response to Acetylcholine

  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).

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

• Cutaneous Conductance (%Baseline) Response to Angiotensin II

  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.

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

Study Arms (2)

Losartan

EXPERIMENTAL

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

Drug: Losartan Potassium

Placebo

PLACEBO COMPARATOR

6 weeks of daily oral placebo tablet

Drug: Placebo

Interventions

Losartan Potassium DRUG

subjects ingest 50mg losartan potassium tablet daily for 6 weeks

Losartan

Placebo DRUG

subjects ingest placebo tablet daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Post-partum women,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Stanhewicz, PhD: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Anna Stanhewicz, PhD
• Organization: University of Iowa

anna-stanhewicz@uiowa.edu

3194671732

Study Officials

• Anna Stanhewicz, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: November 22, 2020
• Primary Completion: June 30, 2024
• Study Completion: March 13, 2025
• Last Updated: July 10, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)