Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Hepatic venous pressure gradient (HVPG) in mmHg units
研究概览
简要总结
It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.
详细描述
The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering resistance that may be responsible for most of cirrhosis complications. Indeed, the potential use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal syndrome are the most harmful consequences of cirrhosis that should be prevented. In that way, simvastatin appears as a promising therapy.The study will include two groups of patients using aleatory randomization and one group will receive simvastatin while the other will receive placebo blindly. At the start and at the end of the study the patients will be submitted to HVPG measurement and azygous vein flow measure.
The endpoints will be the normalization of HVPG or lower significantly(20% or more.
The patients will be followed for 6 months after the end of the study.
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
- Triple (Participant, Care Provider, 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
- •Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
排除标准
- •Child-Pugh C decompensated or encephalopathy
- •Malignancy except basocellular cancer
- •Hepatocarcinoma
- •Anti-viral therapy
- •Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
研究组 & 干预措施
Simvastatin
Arm 1: Simvastatin 40mg / pill, one pill once a day for three months
干预措施: Simvastatin (Drug)
Placebo pill
Arm 2: Placebo one pill once a day for three months
干预措施: Placebo pill (Drug)
结局指标
主要结局
Hepatic venous pressure gradient (HVPG) in mmHg units
时间窗: 3 months
Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure
次要结局
未报告次要终点
研究者
Guilherme Rezende
Associate Professor of the Medical Faculty
Universidade Federal do Rio de Janeiro