Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Virtual portal pressure gradient(vPPG)
研究概览
简要总结
The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
排除标准
- •Treatment with β-blockers or diuretics in the last 3 months
- •Severe cardiopulmonary or renal insufficiency
- •Chronic alcohol abuse
- •Can't tolerate side effects of oral carvedilol or spironolactone
- •History of variceal bleeding
- •Malignancy
- •Portal vein thrombosis
- •History of partial splenic embolization or splenectomy
- •Moderate or tense ascites
研究组 & 干预措施
Carvedilol
Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose
干预措施: Spironolactone and carvedilol (Drug)
Spironolactone and carvedilol
- Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose
- Spironolactone is added after carvedilol being tolerated, which starts with 20mg/d and increases to 40mg/d as a maintainence dose
干预措施: Carvedilol (Drug)
结局指标
主要结局
Virtual portal pressure gradient(vPPG)
时间窗: 6 months
Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound
次要结局
- Liver stiffness measurement (LSM)(6 months)
- Occurence of portal hypertension-related complications(6 months)
研究者
Changqing Yang
MD, PhD
Shanghai Tongji Hospital, Tongji University School of Medicine