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OpenTrials
Completed

NCT Number: NCT00594191

Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

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.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic., Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75.
  • Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
  • Severe sinusoidal portal hypertension (HVPG >12 mmHg)
  • Signed informed consent

Exclusion criteria

  • Pregnancy or lactation
  • Advanced liver disease defined as one of the following: Prothrombin rate <40%, Bilirubin >5 mg/dl, hepatic encephalopathy > grade I or Child-Pugh score >12).
  • Portal vein thrombosis
  • Multinodular hepatocellular carcinoma or single hepatocellular carcinoma > 5 cm.
  • Heart, renal or respiratory failure
  • Previous portal-systemic shunt
  • Treatment with organic nitrates
  • Hypersensitivity to HMG-CoA reductase inhibitors
  • Previous treatment with HMG-CoA reductase inhibitors
  • Treatment with calcium channel blockers

Treatment and study plan

simvastatin

Drug

20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met

Placebo

Drug

Placebo with the same characteristics of the drug and at the same dose

Primary outcomes

  1. Changes in hepatic venous pressure gradient (HVPG)

    Time frame: 4 weeks

Secondary outcomes

  1. Changes in systemic hemodynamics

    Time frame: 4 weeks

  2. Changes in liver function tests

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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.

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jan 15, 2008
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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