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
Recruitment status was Recruiting
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
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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:
Cirrhosis
Esophagus Disorders
High Blood Pressure
Stomach Disorders
Varicose Veins
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 |
| 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
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 | |
| Hospital Gregorio Marañón | Recruiting |
| Madrid, Spain | |
| Contact: Rafael Bañares, MD | |
| Principal Investigator: Rafael Bañares, MD | |
| Clínica Puerta del Hierro | Recruiting |
| Madrid, Spain | |
| Contact: Jose L Calleja, MD | |
| Principal Investigator: Jose L Calleja, 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
No publications provided
| 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:
|
Stomach Diseases Ascites Esophageal Diseases Esophageal and Gastric Varices Hepatic Encephalopathy Hypertension Hypertension, Portal Fibrosis Peritonitis Varicose Veins Pathologic Processes Gastrointestinal Diseases Digestive System Diseases Liver Diseases Liver Failure |
Hepatic Insufficiency Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases Vascular Diseases Cardiovascular Diseases Peritoneal Diseases Propranolol Carvedilol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013