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

The recruitment status of this study is unknown because the information has not been verified recently.

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

History of Changes

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:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Brain Diseases Cirrhosis Stomach Disorders Varicose Veins

Drug Information available for: Propranolol hydrochloride Propranolol Carvedilol Carvedilol hydrochloride

Genetic and Rare Diseases Information Center resources: Hepatic Encephalopathy Esophageal Varices

U.S. FDA Resources

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

Contacts


Contact: Sara Varea	+ 34 932275400 ext 3343	svarea@clinic.ub.es

Locations


Spain
Hospital German Trias i Pujol	Recruiting
Badalona, Spain
Contact: Rosa M Morillas, MD
Principal Investigator: Rosa M Morillas, MD
Hospital Clinic i Provincial de Barcelona	Recruiting
Barcelona, Spain
Contact: Jaume Bosch, MD jbosch@clinic.ub.es
Principal Investigator: Jaume Bosch, MD
Hospital de la Santa Creu i Sant Pau	Recruiting
Barcelona, Spain
Contact: Càndid Villanueva, MD cvillanueva@santpau.cat
Principal Investigator: Càndid Villanueva, MD
Hospital de la Vall d'Hebron	Recruiting
Barcelona, Spain
Contact: Joan Genescà, MD mirenavarro@ir.vhebron.net
Principal Investigator: Joan Genescà, MD
Hospital Arnau de Vilanova	Recruiting
Lérida, Spain
Contact: Carles Aracil, MD
Principal Investigator: Carles Aracil, MD
Clínica Puerta del Hierro	Recruiting
Madrid, Spain
Contact: Jose L Calleja, MD
Principal Investigator: Jose L Calleja, MD
Hospital Gregorio Marañón	Recruiting
Madrid, Spain
Contact: Rafael Bañares, MD
Principal Investigator: Rafael Bañares, MD
Hospital Ramón y Cajal	Recruiting
Madrid, Spain
Contact: Agustin Albillos, MD
Principal Investigator: Agustín Albillos, MD

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:


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

ClinicalTrials.gov processed this record on September 28, 2016

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