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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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 :	January 28, 2010
Actual Primary Completion Date :	July 15, 2015
Actual Study Completion Date :	July 15, 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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. [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. 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 ]
2. Assess the development of liver failure. [ Time Frame: 3 years ]
3. Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment). [ Time Frame: 3 years ]
4. To assess survival. [ Time Frame: 3 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT01059396 History of Changes
Other Study ID Numbers:	PREDESCI
First Posted:	January 29, 2010
Last Update Posted:	August 22, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:

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