cirrhosis and portal hypertension
Conditions
Interventions
experimental group:Carvedilol: patients receive carvedilol, starting with 6.25 mg/day and increased up to 12.5 mg/day. The dose is titrated against clinical tolerance, keeping heart rateabove 55 beats
control group:Placebo: patients receive placebo, starting with 6.25 mg/day and increased up to 12.5 mg/day. The dose
is titrated against clinical tolerance, keeping heart rate above 55 beats per minut
Sponsors
The Sixth People's Hospital of Shenyang
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image; 3. Without any previous decompensation of cirrhosis and without high-risk oesophageal varices (ie, no small varices with red signs, no small varices with Child-Pugh C, no medium or large varices; = 25 kPa' or 'LSM >= 20kPa and PLT< 150 ×10^9/L' or low risk varices; 7. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous decompensation of liver cirrhosis associated with portal hypertension; 2. LSM 150×10^9/L; 3. Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein; 4. Hepatocellular carcinoma demonstrated by imaging tests; 5. Bilirubin > 3 mg/dl, platelets 2 mg/dl); 7. Any comorbidity involving a therapeutic limitation and/or a prognosis of life 5 ULN or AST > 5 ULN; 13. Past treatment with nitrated or ß-blockers in the two weeks prior inclusion; 14. Nonalcoholic steatohepatitis related cirrhosis and body mass index >= 30kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| first decompensation or Liver-related death;overt ascites;esophagogastric variceal bleeding;Changes in platelet count; | — |
Secondary
| Measure | Time frame |
|---|---|
| overt hepatic encephalopathy;the development of spontaneous bacterial peritonitis and other bacterial infections;development of varices;changes in spleen and liver stiffness;changes in spleen stiffness;liver function;hepatocellular carcinoma;development of portal vein thrombosis;adverse events; | — |
Countries
China
Contacts
Public ContactYan Wang
The Sixth People's Hospital of Shenyang
Outcome results
None listed