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

August 21, 2017 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital German Trias i Pujol
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital de la Vall d'Hebron
      • Lérida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Clínica Puerta del Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 3 years
3 years
Assess the development of liver failure.
Time Frame: 3 years
3 years
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
Time Frame: 3 years
3 years
To assess survival.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Càndid Villanueva Sánchez, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2010

Primary Completion (Actual)

July 15, 2015

Study Completion (Actual)

July 15, 2015

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDESCI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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