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

Phase 4

Completed

• Conditions: Esophageal Varices; Portal Hypertension Gastropathy; Spontaneous Bacterial Peritonitis; Hepatic Encephalopathy; Ascites
• Interventions: Drug: placebo; Drug: carvedilol; Drug: propranolol

• Registration Number: NCT01059396
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-28
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Primary Completion: 2015-07-15
• Study Completion: 2015-07-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
carvedilol	carvedilol	-
Propranolol	propranolol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (8)

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

Hospital Arnau de Vilanova; 🇪🇸 Lérida, Spain

Clínica Puerta del Hierro; 🇪🇸 Madrid, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain