Impact of Propranolol on the Prognosis of Patients With Decompensated Cirrhosis and MELD Score > 9

NCT07652203 | Not Yet Recruiting

• 1 other identifier: XHNKKY-NSBBs-2.2
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis

Keywords

cirrhosis; propranolol; decompensation; recompensation; survival; MELD

Outcome Measures

Primary Outcomes (1)

• 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.

  Time to first further decompensation event, assessed from randomization up to the end of the study (maximum of approximately 96 weeks)

Secondary Outcomes (5)

• 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

Study Arms (2)

Conventional treatment without propranolol

EXPERIMENTAL

Patients are provided with conventional supportive treatment only, but without nonselective beta blockers.

Other: conventional therapy

Conventional treatment combined with propranolol

ACTIVE COMPARATOR

Patients are administered with propranolol in addition to conventional treatment.

Drug: propranolol

Interventions

propranolol DRUG

Propranolol 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.

Also known as: Inderal

Conventional treatment combined with propranolol

conventional therapy OTHER

Conventional 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.

Conventional treatment without propranolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Location

Related Publications (5)

• Alvarado-Tapias E, Ardevol A, Garcia-Guix M, Montanes R, Pavel O, Cuyas B, Graupera I, Brujats A, Vilades D, Colomo A, Poca M, Torras X, Guarner C, Concepcion M, Aracil C, Torres F, Villanueva C. Short-term hemodynamic effects of beta-blockers influence survival of patients with decompensated cirrhosis. J Hepatol. 2020 Oct;73(4):829-841. doi: 10.1016/j.jhep.2020.03.048. Epub 2020 Apr 13.

  PMID: 32298768 RESULT

• Serste T, Melot C, Francoz C, Durand F, Rautou PE, Valla D, Moreau R, Lebrec D. Deleterious effects of beta-blockers on survival in patients with cirrhosis and refractory ascites. Hepatology. 2010 Sep;52(3):1017-22. doi: 10.1002/hep.23775.

  PMID: 20583214 RESULT

• Wang T, Wang X, Jia S, Zhao H, Wang L, Zhang X, Fang X, He Y, Li H, Tacke F, Qi X. Impact of non-selective beta blockers on further decompensation and death in decompensated cirrhosis: Benefit and risk stratification by MELD score. Aliment Pharmacol Ther. 2024 Nov;60(10):1409-1420. doi: 10.1111/apt.18261. Epub 2024 Sep 19.

  PMID: 39300691 RESULT

• Cales P, Bertrais S, Boursier J, Fouchard I, Oberti F; SNIFF 16 group. Non-selective beta-blockers increase overall and liver mortality in alcoholic cirrhosis with MELD >/= 12 over 5 years of follow-up. Liver Int. 2021 Jan;41(1):168-179. doi: 10.1111/liv.14674.

  PMID: 32979020 RESULT

• Tittanegro T, China L, Forrest E, Kallis Y, Ryder SD, Wright G, Freemantle N, O'Brien A. Use of non-selective B-blockers is safe in hospitalised decompensated cirrhosis patients and exerts a potential anti-inflammatory effect: Data from the ATTIRE trial. EClinicalMedicine. 2022 Nov 14;55:101716. doi: 10.1016/j.eclinm.2022.101716. eCollection 2023 Jan.

  PMID: 36407574 RESULT

MeSH Terms

Conditions

Fibrosis

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Li He

  Department of Gastroenterology, General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi, MD

CONTACT

18909881019; xingshunqi@126.com

Li He

CONTACT

18473457053; lihee228@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)