Clinical Study of Carvedilol for the Prevention of the Progression of Esophageal Varices in Hepatitis B Related Cirrhotic Patients With Anti-Viral Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- The progression Incidence of esophageal varices.
研究概览
简要总结
Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.
详细描述
It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.
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
- Single (Participant)
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
- •Male or Female;
- •HBV-related liver cirrhotic patients with at least two years of antiviral therapy;
- •The presence of small or medium esophageal varices without red color sign;
- •HBV-DNA<1×10E3 IU/ml
- •Signature of informed consent
排除标准
- •Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);
- •Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR < 50 bpm), cardiogenic shock, hypotension (SBP < 90 mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease.
- •Allergic to Carvedilol;
- •Any malignancy that affects survival；
- •Renal dysfunction；
- •History of beta-blockers within last 3 months；
- •History of surgery for portal hypertension；History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt；
- •Severe systemic diseases；
- •Refusal to participate in the study.
研究组 & 干预措施
Carvedilol+ Nucleos(t)ide Analogues
Based on nucleoside analogue (NUCs), carvedilol will added to the patients. Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute.
干预措施: Carvedilol (Drug)
结局指标
主要结局
The progression Incidence of esophageal varices.
时间窗: 2 years
Progression of esophageal varices defines as follows: 1. Varices developed from small(F1) to medium or large(F2/F3) 2. Varices developed from medium(F2) to large(F3) 3. Bleeding from esophageal varices.
次要结局
- The incidence of liver cirrhosis decompensation(2 years)
- The incidence of hepatic cellular carcinoma, death or liver transplantation.(2 years)
- The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score).(2 years)
- The dynamic change of liver stiffness quantified by transient elastography.(2 years)
- The dynamic change of hemodynamics parameter(2 years)
研究者
Xiaojuan Ou
Director of liver research center
Beijing Friendship Hospital