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

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.

Timeline

Start

2026-06

Primary completion

2027-07

Completion

2028-07

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications