Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Simvastatin

Criteria

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