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

Hepatic Encephalopathy Clinical Trial

— PREDESCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059396
• Other study ID #: PREDESCI
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2010
• Last updated: August 21, 2017
• Start date: January 28, 2010
• Est. completion date: July 15, 2015

Study information

• Verified date: January 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 15, 2015
• Est. primary completion date: July 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma)

• Hypersensitivity to ß-blockers.

• Pregnancy or lactation.

• To receive anticoagulant treatment.

• Past treatment with nitrated or ß-blockers in the two weeks prior inclusion.

• Cirrhosis C virus active antiviral therapy.

Related Conditions & MeSH terms

• Ascites
• Brain Diseases
• Esophageal and Gastric Varices
• Esophageal Varices
• Hepatic Encephalopathy
• Hypertension
• Hypertension, Portal
• Peritonitis
• Portal Hypertension Gastropathy
• Spontaneous Bacterial Peritonitis

Intervention

Drug:
• propranolol
GPVH = 10 mmHg - responders: propranolol.
• carvedilol
GPVH = 10 mmHg nonresponders: carvedilol.
• placebo
placebo propranolol / carvedilol

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assess the development of liver failure.		3 years
Secondary	Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).		3 years
Secondary	To assess survival.		3 years