Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- magnitude of microvascular endothelial function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
研究组 & 干预措施
placebo
placebo pill taken once daily at bedtime for 12 weeks
干预措施: Placebo (Drug)
aspirin
162mg aspirin taken once daily at bedtime for 12 weeks
干预措施: Aspirin (Drug)
结局指标
主要结局
magnitude of microvascular endothelial function
时间窗: baseline, 12 weeks
skin blood flow response to acetylcholine delivered via intradermal microdialysis
magnitude of microvascular endothelin-1 mediated constriction
时间窗: baseline, 12 weeks
skin blood flow response to endothelin-1 delivered via intradermal microdialysis
magnitude of brachial artery endothelial function
时间窗: baseline, 12 weeks
brachial artery flow mediated dilation
次要结局
- magnitude of microvascular nitric oxide-dependent dilation(baseline, 12 weeks)
研究者
Anna Stanhewicz, PhD
Assistant Professor
University of Iowa