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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
201
GPVH ≥ 10 mmHg - responders: propranolol.
GPVH ≥ 10 mmHg nonresponders: carvedilol.
placebo propranolol / carvedilol
Hospital German Trias i Pujol
Badalona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital de la Vall d'Hebron
Barcelona, Spain
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.
Time frame: 3 years
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).
Time frame: 3 years
Assess the development of liver failure.
Time frame: 3 years
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
Time frame: 3 years
To assess survival.
Time frame: 3 years
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Hospital Arnau de Vilanova
Lleida, Spain
Clínica Puerta del Hierro
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain