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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01059396

Collaborator

(none)

201

Enrollment

Locations

Arms

65.5

Actual Duration (Months)

25.1

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension Gastropathy Esophageal Varices Spontaneous Bacterial Peritonitis Hepatic Encephalopathy Ascites	Drug: propranolol Drug: carvedilol Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

201 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Jan 28, 2010

Actual Primary Completion Date :

Jul 15, 2015

Actual Study Completion Date :

Jul 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propranolol	Drug: propranolol GPVH ≥ 10 mmHg - responders: propranolol.
Experimental: carvedilol	Drug: carvedilol GPVH ≥ 10 mmHg nonresponders: carvedilol.
Placebo Comparator: Placebo	Drug: placebo placebo propranolol / carvedilol

Arm

Intervention/Treatment

Experimental: Propranolol

Drug: propranolol

GPVH ≥ 10 mmHg - responders: propranolol.

Experimental: carvedilol

Drug: carvedilol

GPVH ≥ 10 mmHg nonresponders: carvedilol.

Placebo Comparator: Placebo

Drug: placebo

placebo propranolol / carvedilol

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country
1	Hospital German Trias i Pujol	Badalona	Spain
2	Hospital Clinic i Provincial de Barcelona	Barcelona	Spain
3	Hospital de la Santa Creu i Sant Pau	Barcelona	Spain
4	Hospital de la Vall d'Hebron	Barcelona	Spain
5	Hospital Arnau de Vilanova	Lérida	Spain
6	Clínica Puerta del Hierro	Madrid	Spain
7	Hospital Gregorio Marañón	Madrid	Spain
8	Hospital Ramón y Cajal	Madrid	Spain