根据更新的 Baveno VII 共识，建议患有临床显着门静脉高压 (CSPH) 的患者接受非选择性 β 受体阻滞剂（即卡维地洛）治疗，以预防首次肝代偿失调事件。 CSPH定义为肝静脉压力梯度（HVPG）≥10 mm Hg；然而，HVPG 测量由于其侵入性而并未被广泛采用。肝硬度(LS)≥25 kPa可作为HVPG≥10mmHg的替代指标来判断CSPH，在大多数患者的病因学中具有90%的阳性预测值。对于使用 LS≥25 kPa 来诊断 CSPH，然后在代偿性肝硬化患者中启动卡维地洛，目前存在令人信服的争论，并且约 5%-6% 符合此诊断标准的患者可能无法从卡维地洛中受益，并且存在较低的风险心率和平均动脉压。关于使用卡维地洛预防 LS 诊断的 CSPH 肝脏失代偿的随机对照试验仍有待阐明。因此，我们的目的是探讨LS≥25kPa的代偿期肝硬化患者是否可以从卡维地洛治疗中获益。本研究是一项随机、双盲、安慰剂对照、多中心试验。我们将随机分配 446 名 LS≥25kPa、既往无任何失代偿事件且无高危胃食管静脉曲张的成年代偿性肝硬化患者。患者被随机分为两组，A组223名受试者，B组223名受试者。A组为卡维地洛干预组，B组为安慰剂组。两组患者均接受病因治疗，并间隔6个月进行随访。主要结局是肝硬化相关死亡和肝脏相关死亡失代偿事件的 3 年发生率。次要结局包括门静脉高压症每种并发症的单独发生（腹水、静脉曲张出血或明显肝性脑病）、自发性细菌性腹膜炎和其他细菌感染的发生、新静脉曲张的发生、小静脉曲张发展为大静脉曲张、LS 的 Delta 变化脾僵硬、Child-Pugh 评估的肝功能障碍变化和终末期肝病评分模型、血小板计数变化、肝细胞癌的发展、门静脉血栓形成的发展以及 3 年随访的不良事件。将进行预定义的中期分析，以确保计算合理。研究方案已获得沉阳市第六人民医院伦理委员会（2023-05-003-01）和中大临床研究独立伦理委员会批准东南大学附属医院（2023ZDSYLL433-P01）。该试验的结果将提交在同行评审期刊上发表，并将在国际会议上展示。ChiCTR2300073864.© 作者（或其雇主）2024。在 CC BY-NC 下允许重复使用。不得商业再利用。请参阅权利和权限。由英国医学杂志出版。

Patients with clinically significant portal hypertension (CSPH) are recommended to be treated with non-selective beta-blockers (ie, carvedilol) to prevent the first hepatic decompensation event by the renewing Baveno VII consensus. CSPH is defined by hepatic venous pressure gradient (HVPG)≥10 mm Hg; however, the HVPG measurement is not widely adopted due to its invasiveness. Liver stiffness (LS)≥25 kPa can be used as a surrogate of HVPG≥10 mm Hg to rule in CSPH with 90% of the positive predicting value in majority aetiologies of patients. A compelling argument is existing for using LS≥25 kPa to diagnose CSPH and then to initiate carvedilol in patients with compensated cirrhosis, and about 5%-6% of patients under this diagnosis criteria may not be benefited from carvedilol and are at risk of lower heart rate and mean arterial pressure. Randomised controlled trial on the use of carvedilol to prevent liver decompensation in CSPH diagnosed by LS remains to elucidate. Therefore, we aimed to investigate if compensated cirrhosis patients with LS≥25 kPa may benefit from carvedilol therapy.This study is a randomised, double-blind, placebo-controlled, multicentre trial. We will randomly assign 446 adult compensated cirrhosis patients with LS≥25 kPa and without any previous decompensated event and without high-risk gastro-oesophageal varices. Patients are randomly divided into two groups, with 223 subjects in group A and 223 subjects in group B. Group A is a carvedilol intervention group, while group B is a placebo group. All patients in both groups will receive aetiology therapies and are followed up at an interval of 6 months. The 3-year incidences of decompensated events of cirrhosis-related and liver-related death are the primary outcome. The secondary outcomes include development of each complication of portal hypertension individually (ascites, variceal bleeding or overt hepatic encephalopathy), development of spontaneous bacterial peritonitis and other bacterial infections, development of new varices, growth of small varices to large varices, delta changes in LS and spleen stiffness, change in hepatic dysfunction assessed by Child-Pugh and model for end-stage liver disease score, change in platelet count, development of hepatocellular carcinoma, development of portal vein thrombosis and adverse events with a 3-year follow-up. A predefined interim analysis will be performed to ensure that the calculation is reasonable.The study protocol has been approved by the ethics committees of the Sixth People's Hospital of Shenyang (2023-05-003-01) and independent ethics committee for clinical research of Zhongda Hospital, affiliated to Southeast University (2023ZDSYLL433-P01). The results from this trial will be submitted for publication in peer-reviewed journals and will be presented at international conferences.ChiCTR2300073864.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.