Clinical trial NCT01059396: Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Study on the Effectiveness of Treatment With Beta-blockers to Prevent Decompensation of Cirrhosis With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Portal Hypertension Gastropathy
Esophageal Varices
Spontaneous Bacterial Peritonitis
Hepatic Encephalopathy
Ascites
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 80 years old.
* With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image.
* No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (\<3 months before randomization).
* Absence of ascites demonstrated by a recent ultrasound (\<3 months before the randomization).
* informed consent

Exclusion Criteria:

* previous decompensation of liver cirrhosis associated with portal hypertension.
* GPVH \<10 mmHg.
* Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein.
* Hepatocellular carcinoma demonstrated by two imaging tests.
* Bilirubin\> 3 mg / dl (or\> 50 micromol / l), platelets \<30 x10E9/lo Quick \<30%.
* Presence of renal insufficiency (serum creatinine\> 2 mg / dl or\> 200 micromol / l).
* Any comorbidity involving a therapeutic limitation and / or a prognosis of life \<12 months.
* Absolute contraindication to treatment with β-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma)
* Hypersensitivity to β-blockers.
* Pregnancy or lactation.
* To receive anticoagulant treatment.
* Past treatment with nitrated or β-blockers in the two weeks prior inclusion.
* Cirrhosis C virus active antiviral therapy.

Primary outcomes:
measure: Appearance of complications of portal hypertension: bleeding (caused by portal hypertension gastropathy and / or esophageal varices), ascites and / or spontaneous bacterial peritonitis(PBE), hepatic encephalopathy. Death from any cause.
timeFrame: 3 years
Secondary outcomes:
measure: Compare the appearance of each of the complications of portal hypertension (ascites, SBP and other bacterial infections, varicose veins or signs of high risk, upper gastrointestinal bleeding portal hypertension, hepatic encephalopathy).
timeFrame: 3 years
measure: Assess the development of liver failure.
timeFrame: 3 years
measure: Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
timeFrame: 3 years
measure: To assess survival.
timeFrame: 3 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital German Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de la Vall d'Hebron
city: Lérida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Clínica Puerta del Hierro
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Càndid Villanueva Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Brujats A, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J; PreDesCI Study Investigators. Bacterial infections adversely influence the risk of decompensation and survival in compensated cirrhosis. J Hepatol. 2021 Sep;75(3):589-599. doi: 10.1016/j.jhep.2021.04.022. Epub 2021 Apr 24.
citation: Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.