Overview

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.