Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring
试验速览
- 阶段
- 4 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
研究概览
简要总结
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile.
The purpose of this study is to determine the effect of Simvastatin on the blood pressure
详细描述
This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients with controlled or uncontrolled blood pressure
排除标准
- •Secondary causes of hypertension;
- •Systolic Blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg
- •Complain of side effects related to Statins
- •Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease)
- •Renal disease (creatinine > 1,5 mgdl).
研究组 & 干预措施
1
Simvastatin 40 mg
干预措施: Simvastatin 40mg (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM)
时间窗: Eigth weeks
次要结局
未报告次要终点