Phase IV-II Randomized, Multicenter, Placebo-Controlled Double-Blind Clinical Trial Evaluating the Effects of Continuous Simvastatin Administration on Hepatic and Systemic Hemodynamics in Patients With Cirrhosis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Changes in hepatic venous pressure gradient (HVPG)
研究概览
简要总结
The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.
详细描述
Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and
- •Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
- •Severe sinusoidal portal hypertension (HVPG >12 mmHg)
- •Signed informed consent
排除标准
- •Pregnancy or lactation
- •Advanced liver disease defined as one of the following: Prothrombin rate <40%, Bilirubin >5 mg/dl, hepatic encephalopathy > grade I or Child-Pugh score >12).
- •Portal vein thrombosis
- •Multinodular hepatocellular carcinoma or single hepatocellular carcinoma > 5 cm.
- •Heart, renal or respiratory failure
- •Previous portal-systemic shunt
- •Treatment with organic nitrates
- •Hypersensitivity to HMG-CoA reductase inhibitors
- •Previous treatment with HMG-CoA reductase inhibitors
- •Treatment with calcium channel blockers
研究组 & 干预措施
A
Placebo treatment
干预措施: Placebo (Drug)
B
干预措施: Simvastatin (Drug)
结局指标
主要结局
Changes in hepatic venous pressure gradient (HVPG)
时间窗: 4 weeks
次要结局
- Changes in systemic hemodynamics(4 weeks)
- Changes in liver function tests(4 weeks)