Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter, Randomized, Double-blind, Placebo-controlled Study on the Effectiveness of Treatment With Beta-blockers to Prevent Decompensation of Cirrhosis With Portal Hypertension

Conditions
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Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis, Hepatic Encephalopathy, Ascites

Intervention / Treatment
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* Drug: propranolol
* Drug: carvedilol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propranolol<br> | Drug: propranolol<br>* GPVH ≥ 10 mmHg - responders: propranolol.<br>|
| Experimental: carvedilol<br> | Drug: carvedilol<br>* GPVH ≥ 10 mmHg nonresponders: carvedilol.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo propranolol / carvedilol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |