NCT00594191

Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

Phase IV-II Randomized, Multicenter, Placebo-Controlled Double-Blind Clinical Trial Evaluating the Effects of Continuous Simvastatin Administration on Hepatic and Systemic Hemodynamics in Patients With Cirrhosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.

Detailed description

Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.

Conditions

• Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Simvastatin	20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
DRUG	Placebo	Placebo with the same characteristics of the drug and at the same dose

Timeline

• Start date: 2004-03-01
• Primary completion: 2007-04-01
• Completion: 2007-11-01
• First posted: 2008-01-15
• Last updated: 2008-01-15

Locations

3 sites across 1 country: Spain