NCT01059396

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2015

Completed
Last Updated

August 22, 2017

Status Verified

January 1, 2017

Enrollment Period

5.5 years

First QC Date

January 28, 2010

Last Update Submit

August 21, 2017

Conditions

Portal Hypertension GastropathyEsophageal VaricesSpontaneous Bacterial PeritonitisHepatic EncephalopathyAscites

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (3)

Propranolol

EXPERIMENTAL
Drug: propranolol

carvedilol

EXPERIMENTAL
Drug: carvedilol

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

propranololDRUG

GPVH ≥ 10 mmHg - responders: propranolol.

Propranolol
carvedilolDRUG

GPVH ≥ 10 mmHg nonresponders: carvedilol.

carvedilol
placeboDRUG

placebo propranolol / carvedilol

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Cirrhosis C virus active antiviral therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital German Trias i Pujol

Badalona, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital de la Vall d'Hebron

Barcelona, Spain

Location

Hospital Arnau de Vilanova

Lleida, Spain

Location

Clínica Puerta del Hierro

Madrid, Spain

Location

Hospital Gregorio Marañón

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Related Publications (2)

  • Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Brujats A, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J; PreDesCI Study Investigators. Bacterial infections adversely influence the risk of decompensation and survival in compensated cirrhosis. J Hepatol. 2021 Sep;75(3):589-599. doi: 10.1016/j.jhep.2021.04.022. Epub 2021 Apr 24.

    PMID: 33905794DERIVED

  • Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.

    PMID: 30910320DERIVED

MeSH Terms

Conditions

Esophageal and Gastric VaricesHepatic EncephalopathyAscites

Interventions

PropranololCarvedilol

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver DiseasesLiver FailureHepatic InsufficiencyBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

  • Càndid Villanueva Sánchez, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

January 28, 2010

Primary Completion

July 15, 2015

Study Completion

July 15, 2015

Last Updated

August 22, 2017

Record last verified: 2017-01

Locations

ES(8)