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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
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.
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
The progression Incidence of esophageal varices.
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.
Time frame: 2 years
The incidence of liver cirrhosis decompensation
Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy) after 2 year.
Time frame: 2 years
The incidence of hepatic cellular carcinoma, death or liver transplantation.
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation after 2 year.
Time frame: 2 years
The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score).
The progression rate of Child-Pugh、MELD、APRI、FIB-4 score after 2 years.
Time frame: 2 years
The dynamic change of liver stiffness quantified by transient elastography.
The dynamic change of liver stiffness quantified by transient elastography after 2 years.
Time frame: 2 years
The dynamic change of hemodynamics parameter
The dynamic change of hemodynamics (HR and mean arterial pressure) after 2 years.
Time frame: 2 years
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China