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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase

Completed

Phase 4

Conditions

Portal Hypertension Gastropathy

Hepatic Encephalopathy

Esophageal Varices

Spontaneous Bacterial Peritonitis

Ascites

Treatments

Drug: placebo

Drug: propranolol

Drug: carvedilol

Study type

Interventional

Funder types

Other

Identifiers

NCT01059396

PREDESCI

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.