Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patients with Reduced Portal Pressure After Intervention
研究概览
简要总结
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.
详细描述
Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
- •Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)
排除标准
- •Pregnancy
- •Hepatic encephalopathy grade III-IV
- •Hepatocellular carcinoma
- •Treatment with statins in the previous 3 months
- •Hypersensitivity to statins
- •Previous surgical shunt or TIPS
- •Treatment with calcium channel blockers
研究组 & 干预措施
Simvastatin
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks
干预措施: Simvastatin (Drug)
结局指标
主要结局
Number of Patients with Reduced Portal Pressure After Intervention
时间窗: 6 Months
the number of Patients with Reduced Portal Pressure After Intervention
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Principle investigator
Tanta University