Preeclampsia: A Marker for Future Cardiovascular Risk in Women
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vascular function
研究概览
简要总结
This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy.
This study will take place over the course of 2 weeks. Each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
- •Age 21 to 50 years
- •Systolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit
- •Body mass index < 35 kg/m2
- •History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
- •No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)
排除标准
- •Current pregnancy
- •Elevated blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
- •Current diagnosis of hypertension
- •Current diagnosis of diabetes mellitus
- •Personal history of coronary disease, stroke and kidney disease
- •Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
- •Use of oral contraceptives or other hormone therapy within 3 months of study;
- •Renal impairment (estimated GFR<60)
- •Active liver disease (AST, ALT, alkaline phosphatase > 1.5 times normal);
- •Current smoking, defined as smoking within the 6 months before the screening visit
- •Current or past recreational drug use
研究组 & 干预措施
Single arm intervention
Irbesartan 150 mg orally for one dose
干预措施: Irbesartan (Drug)
结局指标
主要结局
Vascular function
时间窗: 60 minutes
Assess vascular function after administration of an angiotensin receptor blocker.
次要结局
- Hormonal measurements(60 minutes)
研究者
Ellen W. Seely
M.D.
Brigham and Women's Hospital