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

• Status: Completed
• Trial end date: 2015-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Treatments: Carvedilol; Propranolol

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.