Effects and Underlying Mechanism of Lipid Lowering Intervention on Vascular Protection in Hypertensive Patients (EMINENT Study)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary endpoint is the Flow Mediated Dilatation (FMD)
研究概览
简要总结
The purpose of EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin in hypertensive patients at low/moderate cardiovascular risk.
详细描述
EMINENT study is to evaluate the efficacy of Xuezhikang or atorvastatin on vascular function protection in hypertensive patients at low/moderate cardiovascular risk.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must meet the hypertension with low or moderate cardiovascular risk following 2010 Guidelines for prevention and treatment of hypertension in China
排除标准
- •Secondary Hypertension
- •Women who are pregnant or lactating
- •History of mental instability, or major psychiatric illness not adequately controlled and stable on therapy
- •Type 2 Diabetes
- •Active liver disease or impaired liver function tests
- •Impaired renal function
- •Uncontrolled cardiac arrhythmia
- •Patient who is unable to give informed consent
- •Any condition or situation, which in the opinion of the investigator, might pose a risk to the patient or confound the results of the study
研究组 & 干预措施
Normal-dose statin
Lifestyle modification with Normal-dose statin
干预措施: Atorvastatin (Drug)
Normal-dose statin
Lifestyle modification with Normal-dose statin
干预措施: Lifestyle modification (Behavioral)
Lifestyle modification + Xuezhikang
Lifestyle changes with Xuezhikang
干预措施: Xuezhikang (Drug)
Lifestyle modification + Xuezhikang
Lifestyle changes with Xuezhikang
干预措施: Lifestyle modification (Behavioral)
Lifestyle modification
Lifestyle modification
干预措施: Lifestyle modification (Behavioral)
结局指标
主要结局
The primary endpoint is the Flow Mediated Dilatation (FMD)
时间窗: 1 year
次要结局
- lipid profiles(1 year)
- the carotid - femoral Pulse Wave Velocity (cf-PWV),(1 year)
- inflammatory markers(1 year)
研究者
Aimin Dang
Cardiovascular Institute & Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital