Non selective beta blockers (NSBBs), such as propranolol and nadolol, are mainstay therapies for portal hypertension in cirrhosis, but their efficacy and safety vary depending on the stage of the disease. Emerging evidence suggests that NSBBs may worsen the prognosis of advanced cirrhosis, especially in patients with a model for end-stage liver disease (MELD) score of \>9. The purpose of this randomized controlled trial is to evaluate the effects of the use of propranolol as recommended by the guideline on the prognosis in cirrhotic patients with a MELD score of \>9.
patients' age ≥18 years;
patients with a definitive diagnosis of liver cirrhosis;
patients with a MELD score of >9;
patients with a history of decompensation or those who are experiencing their first decompensation, such as ascites, variceal bleeding, or hepatic encephalopathy (HE);
patients without a definite indication for NSBBs;
patients with an absolute contraindication of NSBBs (severe bronchospasm, asthma, severe psychosis, high-degree atrioventricular block, etc.);
patients with hypersensitivity to NSBBs;
patients who had been treated with NSBBs before 2 weeks of enrollment;
Parallel
conventional therapy
Other interventionConventional treatment of decompensated cirrhosis mainly includes anti-hepatic fibrosis drugs, albumin infusion, diuretics, peritoneal drainage, esophageal variceal ligation, endoscopic tissue adhesive injection, blood purification, and liver transplantation.
propranolol
DrugPropranolol will be started with 10-20 mg/day for the propranolol group, which will be gradually increased to the maximum tolerance dosage or achieve a heart rate of 55-60 beats per minute and a systolic blood pressure of 90mmHg.
The time from randomization to the occurrence of further decompensation
Further decompensation is defined as any of the following conditions: 1. the occurrence of a second portal hypertension driven decompensation event (ascites, variceal bleeding or HE) and/or non-obstructive jaundice; 2. the occurrence of recurrent variceal bleeding, refractory ascites, recurrent HE, SBP, and/or HRS-AKI; 3. the occurrence of ascites, HE, or jaundice in patients with bleeding alone after recovery from bleeding, according to the Baveno VII consensus.
The time from randomization to the occurrence of recompensation
Recompensation is defined as all of the following criteria are met: 1. removal/suppression/cure of the primary cause of cirrhosis (e.g., removal of hepatitis C virus, sustained suppression of hepatitis B virus, or sustained alcohol abstinence in alcoholic cirrhosis); 2. resolution of ascites in the setting of discontinuation of diuretics, absence of HE in the setting of discontinuation of lactulose/rifaximin, and absence of recurrent variceal bleeding within at least 12 months; 3. stable improvement of liver function (e.g., albumin, international normalized ratio, bilirubin)
The time from randomization to the occurrence of death
All-cause mortality during the study period
The composite endpoint of further decompensation and death
The hierarchical composite endpoint of death and further decompensation
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