Simvastatin Effect on Portal Hypertension

Study Overview
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Brief Summary
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It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.

Detailed Description
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The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering resistance that may be responsible for most of cirrhosis complications. Indeed, the potential use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal syndrome are the most harmful consequences of cirrhosis that should be prevented. In that way, simvastatin appears as a promising therapy.The study will include two groups of patients using aleatory randomization and one group will receive simvastatin while the other will receive placebo blindly. At the start and at the end of the study the patients will be submitted to HVPG measurement and azygous vein flow measure. The endpoints will be the normalization of HVPG or lower significantly(20% or more. The patients will be followed for 6 months after the end of the study.

Official Title
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Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy

Conditions
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Portal Hypertension, Esophageal Varices, Liver Cirrhosis

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Placebo pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome. Exclusion Criteria: Child-Pugh C decompensated or encephalopathy Malignancy except basocellular cancer Hepatocarcinoma Anti-viral therapy HIV Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>Arm 1: Simvastatin 40mg / pill, one pill once a day for three months | Drug: Simvastatin<br>* 40mg / pill, one pill orally once a day for three months<br>|
| Placebo Comparator: Placebo pill<br>Arm 2: Placebo one pill once a day for three months | Drug: Placebo pill<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic venous pressure gradient (HVPG) in mmHg units | Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG