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

Primary Purpose

Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
propranolol
carvedilol
placebo
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Hypertension Gastropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Propranolol

carvedilol

Placebo

Arm Description

Outcomes

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.

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).
Assess the development of liver failure.
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
To assess survival.

Full Information

First Posted
January 28, 2010
Last Updated
August 21, 2017
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01059396
Brief Title
Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 28, 2010 (Actual)
Primary Completion Date
July 15, 2015 (Actual)
Study Completion Date
July 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension Gastropathy, Esophageal Varices, Spontaneous Bacterial Peritonitis, Hepatic Encephalopathy, Ascites

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Title
carvedilol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Description
GPVH ≥ 10 mmHg - responders: propranolol.
Intervention Type
Drug
Intervention Name(s)
carvedilol
Intervention Description
GPVH ≥ 10 mmHg nonresponders: carvedilol.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo propranolol / carvedilol
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Assess the development of liver failure.
Time Frame
3 years
Title
Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).
Time Frame
3 years
Title
To assess survival.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Càndid Villanueva Sánchez, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital German Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital de la Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lérida
Country
Spain
Facility Name
Clínica Puerta del Hierro
City
Madrid
Country
Spain
Facility Name
Hospital Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33905794
Citation
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.
Results Reference
derived
PubMed Identifier
30910320
Citation
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. Erratum In: Lancet. 2019 Jun 22;393(10190):2492.
Results Reference
derived

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

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