Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- The time from randomization to the occurrence of further decompensation
研究概览
简要总结
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.
详细描述
This is a non-inferiority, randomized controlled trial. A total of 466 decompensated cirrhotic patients with a MELD score of >9 will be enrolled. Participants will be stratified based on the presence or absence of acute decompensation at enrollment, and then randomly assigned at a 1:1 ratio to conventional treatment combined with or without propranolol groups. All patients will receive standard medical therapy in both groups, and then regularly followed. The primary outcome is further decompensation. The secondary outcomes include recompensation and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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' informed consents.
排除标准
- •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;
- •patients with occlusive portal vein thrombosis;
- •patients who had undergone liver transplantation;
- •patients who had undergone transjugular intrahepatic portosystemic shunt (TIPS);
- •patients with a definitive diagnosis of hepatocellular carcinoma;
- •patients with an estimated life time of <12 months due to the presence of any comorbidities;
- •patients who are currently pregnant or breast-feeding.
研究组 & 干预措施
Conventional treatment without propranolol
Patients are provided with conventional supportive treatment only, but without nonselective beta blockers.
干预措施: conventional therapy (Other)
Conventional treatment combined with propranolol
Patients are administered with propranolol in addition to conventional treatment.
干预措施: propranolol (Drug)
结局指标
主要结局
The time from randomization to the occurrence of further decompensation
时间窗: Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
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.
次要结局
- The time from randomization to the occurrence of recompensation(Time to first recompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks))
- The time from randomization to the occurrence of death(assessed from randomization up to the end of the study (maximum of approximately 96 weeks))
- The composite endpoint of further decompensation and death(assessed from randomization up to the end of the study (maximum of approximately 96 weeks))
- The hierarchical composite endpoint of death and further decompensation(assessed from randomization up to the end of the study (maximum of approximately 96 weeks))
- The time from randomization to the occurrence of individual decompensation events(assessed from randomization up to the end of the study (maximum of approximately 96 weeks)
研究者
Xingshun Qi
Director of Department of Gastroenterology
General Hospital of Shenyang Military Region