Role of Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclamptic Pregnancy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo Oral Tablet (Drug)
Salsalate
干预措施: Salsalate Oral Tablet (Drug)
结局指标
主要结局
Microvascular Endothelial Function (Cutaneous Conductance, %Maximum)
时间窗: 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.
次要结局
- Peripheral Blood Mononuclear Cell Inflammatory Response to Ang II(at the completion of 4 days of oral (placebo or salsalate) treatment)
研究者
Anna Stanhewicz, PhD
Principal Investigator
University of Iowa