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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00594191

Enrollment

Registered

2008-01-15

Start date

2004-03-31

Completion date

2007-11-30

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension

Keywords

Statins, HMG-CoA reductase inhibitors, Cirrhosis, Portal hypertension, Variceal bleeding

Brief 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.

Interventions

DRUGSimvastatin

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age between 18 and 75. 2. Clinical, analytical, ultrasound or pathological criteria of cirrhosis. 3. Severe sinusoidal portal hypertension (HVPG \>12 mmHg) 4. Signed informed consent

Exclusion criteria

1. Pregnancy or lactation 2. 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). 3. Portal vein thrombosis 4. Multinodular hepatocellular carcinoma or single hepatocellular carcinoma \> 5 cm. 5. Heart, renal or respiratory failure 6. Previous portal-systemic shunt 7. Treatment with organic nitrates 8. Hypersensitivity to HMG-CoA reductase inhibitors 9. Previous treatment with HMG-CoA reductase inhibitors 10. Treatment with calcium channel blockers

Design outcomes

Primary

Measure	Time frame
Changes in hepatic venous pressure gradient (HVPG)	4 weeks

Secondary

Measure	Time frame
Changes in systemic hemodynamics	4 weeks
Changes in liver function tests	4 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026