Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal (PREDESCI)
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ClinicalTrials.gov Identifier: NCT01059396 |
Recruitment Status
:
Completed
First Posted
: January 29, 2010
Last Update Posted
: August 22, 2017
|
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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 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 |

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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01059396
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 |
Principal Investigator: | Càndid Villanueva Sánchez, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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 Key Record Dates |
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 |