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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propranolol | Experimental |
| |
| carvedilol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol | Drug | GPVH ≥ 10 mmHg - responders: propranolol. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 years | |
| Assess the development of liver failure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Càndid Villanueva Sánchez, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital German Trias i Pujol | Badalona | Spain | ||||
| Hospital Clinic i Provincial de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33905794 | Derived | Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Brujats A, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J; PreDesCI Study Investigators. Bacterial infections adversely influence the risk of decompensation and survival in compensated cirrhosis. J Hepatol. 2021 Sep;75(3):589-599. doi: 10.1016/j.jhep.2021.04.022. Epub 2021 Apr 24. | |
| 30910320 |
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| carvedilol |
| Drug |
GPVH ≥ 10 mmHg nonresponders: carvedilol. |
|
| placebo | Drug | placebo propranolol / carvedilol |
|
| 3 years |
| Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment). | 3 years |
| To assess survival. | 3 years |
| Barcelona |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital de la Vall d'Hebron | Barcelona | Spain |
| Hospital Arnau de Vilanova | Lleida | Spain |
| Clínica Puerta del Hierro | Madrid | Spain |
| Hospital Gregorio Marañón | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Derived |
| Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22. |
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| D006501 | Hepatic Encephalopathy |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
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