Ascites, Esophageal Varices, Hepatic Encephalopathy, Portal Hypertension Gastropathy, Spontaneous Bacterial Peritonitis
Conditions
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.
Interventions
DRUGpropranolol
GPVH ≥ 10 mmHg - responders: propranolol.
DRUGcarvedilol
GPVH ≥ 10 mmHg nonresponders: carvedilol.
DRUGplacebo
placebo propranolol / carvedilol
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 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). | 3 years |
| Assess the development of liver failure. | 3 years |
| Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment). | 3 years |
| To assess survival. | 3 years |
Countries
Spain
Outcome results
None listed