Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia? (PVS3)
Can Atorvastatin Improve Vascular Function in Women With a History of Preeclampsia? A Randomised, Double-blinded, Placebo-controlled Crossover Trial of Atorvastatin in Women With a History of Preeclampsia.
研究概览
详细说明
Women with a history of preeclampsia (high blood pressure/protein in the urine during pregnancy) are at increased risk of developing high blood pressure and heart problems in the 10-15 years after their baby is born. At present we do not know how to reduce this risk. Lowering blood pressure and blood lipid (fats) levels are common strategies for primary prevention of cardiovascular problems. However, most women with a history of preeclampsia in the 5-10 years after pregnancy, will have normal blood pressure readings, blood sugar and cholesterol levels.
Atorvastatin, a type of "statin", is widely used in lowering lipids and preventing cardiovascular disease. This drug has beneficial actions other than lipid-lowering, that may also help prevent cardiovascular problems, including improving function in the lining of blood vessels. We know that impairment in blood vessel function is evident in women in the years after a preeclamptic pregnancy and may contribute to the risk of women after preeclampsia going on to develop cardiovascular disease.
We would like to know if giving a short course of atorvastatin to women with a history of preeclampsia improves their blood vessel function. To do this, ex-preeclamptic women will be invited to take either a atorvastatin or placebo ("dummy") tablet daily for 4 weeks, then no tablets for 4 weeks, then "crossover" to receive the alternative tablet (placebo or atorvastatin) daily for 4 weeks. Blood vessel function would be measured using specialised noninvasive scans and taking a blood test at the beginning and end of each treatment period. The study will be jointly run by the Departments of Cardiovascular Medicine and Obstetrics & Gynaecology at the John Radcliffe Hospital, Oxford.
We anticipate this study will provide valuable data to support larger clinical trials to determine whether improving blood vessel function ultimately reduces the risk of developing early-onset cardiovascular disease after preeclampsia.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Oxford、英国、OX3 9DU
- University of Oxford Department of Cardiovascular Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Diagnosed with preeclampsia during index pregnancy: defined as (1) new onset hypertension (>140/90 mmHg) after 20 weeks gestation and (2) proteinuria (>0.3g protein/24 hours).
- Participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 weeks after.
- Participants must be willing to undertake urine pregnancy test at the start of each 4 week phase of the study to exclude unintended pregnancy.
- Participants must have clinically acceptable laboratory markers of renal, thyroid and hepatic function at enrolment.
- Able (in the Investigator's opinion) and willing to comply with all study requirements.
- Willing to allow her General Practitioner and consultant, if appropriate, to be notified of participation in the study and results of clinical laboratory tests.
Exclusion Criteria:
Participants must not be
- Pregnant, lactating during the course of the study.
- Planning pregnancy during course of study or in 4 weeks after study completion
- Taking other medication, whether prescribed or over-the-counter, in the four weeks before first study dose and during the study other than for example mild analgesia or hormonal contraception.
- Taking vitamin medications that may interact with atorvastatin (e.g. niacin, Vitamin D)
- Terminally ill or is inappropriate for placebo medication
- Planning to undertake donation of blood during the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Atorvastatin first
Participants receive 4 week treatment with atorvastatin 20mg/day, followed by 4 week washout, followed by 4 week treatment with placebo.
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4 week treatment, 20mg/day taken orally in tablet form
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实验性的：Placebo first
Participants receive 4 week treatment with placebo, followed by 4 weeks washout, followed by 4 weeks treatment with atorvastatin 20mg/day.
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4 week treatment, 20mg/day taken orally in tablet form
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Alteration in brachial artery flow-mediated dilatation
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Microvascular endothelial function as measured by laser doppler flowmetry
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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Resistance vessel endothelial function as measured by venous occlusion plethysmography
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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Indices of arterial stiffness as measured by arterial tonometry and carotid artery distensibility
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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Plasma biomarkers of inflammation and endothelial function
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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Endothelial glycocalyx as measured by sublingual Microscan
大体时间：After 4 weeks treatment with atorvastatin or placebo
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After 4 weeks treatment with atorvastatin or placebo
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合作者和调查者
调查人员
- 首席研究员：Paul Leeson, PhD MRCP FESC、University of Oxford
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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