Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- magnitude of microvascular endothelial function
Study Overview
Brief Summary
Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •had preeclampsia in the past 5 years,
- •18 years or older
- •Exclusion criteria:
- •current daily aspirin use,
- •skin diseases,
- •current tobacco or nicotine use (including vaping),
- •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,
- •currently pregnancy,
- •body mass index <18.5 kg/m2,
- •allergy to materials used during the experiment.(e.g. latex),
- •known allergies to study drugs,
- •bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).
Exclusion Criteria
- Not provided
Arms & Interventions
placebo
placebo pill taken once daily at bedtime for 12 weeks
Intervention: Placebo (Drug)
aspirin
162mg aspirin taken once daily at bedtime for 12 weeks
Intervention: Aspirin (Drug)
Outcomes
Primary Outcomes
magnitude of microvascular endothelial function
Time Frame: baseline, 12 weeks
skin blood flow response to acetylcholine delivered via intradermal microdialysis
magnitude of microvascular endothelin-1 mediated constriction
Time Frame: baseline, 12 weeks
skin blood flow response to endothelin-1 delivered via intradermal microdialysis
magnitude of brachial artery endothelial function
Time Frame: baseline, 12 weeks
brachial artery flow mediated dilation
Secondary Outcomes
- magnitude of microvascular nitric oxide-dependent dilation(baseline, 12 weeks)
Investigators
Anna Stanhewicz, PhD
Assistant Professor
University of Iowa