Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01059396
First received: January 28, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose
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 Intervention Phase
Portal Hypertension Gastropathy
Esophageal Varices
Spontaneous Bacterial Peritonitis
Hepatic Encephalopathy
Ascites
Drug: propranolol
Drug: carvedilol
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

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. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Assess the development of liver failure. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To assess survival. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: September 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059396

Locations
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, Spain
Sponsors and Collaborators
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
  More Information

Responsible Party: Clinical Trials Unit - Hospital Clínic de Barcelona, CTU Clínic
ClinicalTrials.gov Identifier: NCT01059396     History of Changes
Other Study ID Numbers: PREDESCI 
Study First Received: January 28, 2010
Last Updated: June 21, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Hypertension
Brain Diseases
Hepatic Encephalopathy
Hypertension, Portal
Ascites
Peritonitis
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Pathologic Processes
Intraabdominal Infections
Infection
Peritoneal Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carvedilol
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016