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Completed

NCT Number: NCT03482440

Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa, Iowa City, Iowa, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Salsalate Oral Tablet

Drug

1500mg twice daily for 4 days prior to experimental testing

Placebo oral tablet

Drug

Placebo oral table twice daily for 4 days prior to experimental testing

Primary outcomes

  1. Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)

    Time frame: immediately following the 4 days or oral treatment (salsalate or placebo)

    Endothelium-dependent vasodilation assessed as cutaneous conductance response (cutaneous conductance = local red blood cell flux/mean arterial pressure; %maximum) to exogenous acetylcholine delivered via intradermal microdialysis.

Secondary outcomes

  1. Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II

    Time frame: at the completion of 4 days of oral (placebo or salsalate) treatment

    inflammatory cytokine (TNFalpha) release by peripheral blood mononuclear cells isolated from fresh whole blood collected via venipuncture and stimulated with angiotensin II ex vivo.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Penn State University

Registry information

Official study title

Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Mar 29, 2018
Registry last updated
Jun 3, 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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