Study About Simvastatin in Portal Hypertension in Compensated Cirrhosis

• Status: Unknown status
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether simvastatin is effective in the prevention of progression of porta hypertension in compensated cirrhosis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborator: Instituto de Salud Carlos III
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Liver cirrhosis diagnosed by previous biopsy or by clinical, laboratory, ultrasound

• Portal hypertension gradient between6 mmHg and10 mmHg

• Absence of esophageal and gastric varices or small esophageal varices without red signs

• Absence previous episodes of gastrointestinal hemorrhage, ascites, encephalopathy or jaundice

• Written informed consent

Exclusion Criteria:

• Age <18 and> 80 years,

• Presence or history of ascites, clinical or ultrasound,

• Previous decompensation of liver cirrhosis, ascites or SBP, bleeding varices, large varices, hepatic encephalopathy, jaundice,

• Thrombosis splenoportal,

• Hepatocellular carcinoma;

• Child-Pugh >7 point

• Any comorbidity that leads to a restriction therapy and / or a life expectancy <12 months

• Absolute contraindication to treatment with statins or allergy Simvastatin;

• Concomitant potent CYP3A4 inhibitors (eg., itraconazole, ketoconazole, protease inhibitors, HIV, erythromycin, clarithromycin, telithromycin and nefazodone),

• Pretreatment (<1 month) with simvastatin or other lipid-lowering,

• Previous episodes of rhabdomyolysis,

• Active alcoholic hepatitis,

• Refusal to participate in the study or the informed consent claim;

• Pre-treatment with beta blockers or nitrates, or endoscopic treatment for varicose veins or portosystemic derivations;

• Pregnancy and lactation.