Recruiting
Early Phase 1

Aspirin

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT05653973

Conditions

Preeclampsia

Microvascular Function

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Acetylcholine

Endothelin-1

Study Details

Brief summary:

Preeclampsia is a pregnancy disorder affecting \~5-10% of pregnancies in the United States. 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. Low dose aspirin (LDA; 75-150mg/daily) is currently the most effective and clinically accepted therapy for reducing preeclampsia prevalence in women at high risk for developing the syndrome. The purpose of this study is to interrogate the mechanisms by which LDA therapy mitigates persistent vascular dysfunction in postpartum women who have had preeclampsia.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had a history of preeclampsia. As a compliment to these measurements, they also draw blood from the subjects and isolate the inflammatory cells.

Conditions

Preeclampsia

Microvascular Function

Study ID

NCT05653973

Start date

Jan 3, 2023

Status verified date

May, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion:

  • 18 years or older,
  • 12 weeks to 5 years postpartum
  • and one of the following:

1. women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy,
2. women who had a normal pregnancy and used LDA during pregnancy,
3. women who had preeclampsia and did not use LDA during pregnancy,
4. women who had preeclampsia and used LDA during pregnancy.

Exclusion:

  • current daily aspirin use,
  • 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,
  • 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

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: assessment of microvascular function

The investigators use intradermal microdialysis to deliver acetylcholine, acetylcholine + L-NAME, endothelin-1, endothelin-1 + BQ-788, and endothelin-1 + BQ-123 to the cutaneous microvasculature.

Interventions

Acetylcholine

acetylcholine, and acetylcholine + L-NAME (Nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelium- and nitric oxide-dependent dilation

Endothelin-1

endothelin-1, endothelin-1 + BQ-788 (endothelin receptor type B-inhibitor), and endothelin-1 + BQ-123 (endothelin receptor type A-inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelin-mediated constriction and the role of the receptor subtypes in this response.

Primary outcome measure

  • microvascular endothelial function [ Time Frame: at the study visit, an average of 4 hours ]
  • microvascular endothelin-1-mediated constriction [ Time Frame: at the study visit, an average of 4 hours ]

Central Contacts and Locations

Central contacts

Anna Reid-Stanhewicz, PHD

319-467-1732anna-stanhewicz@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Anna Stanhewicz, PhD

319-467-1732anna-stanhewicz@uiowa.edu

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

May 31, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2025-05-31.