Simvastatin Effect on Portal Hypertension

Phase 3

Completed

• Conditions: Portal Hypertension; Esophageal Varices; Liver Cirrhosis
• Interventions: Drug: Simvastatin; Drug: Placebo pill

• Registration Number: NCT02134626
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-04-04
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Study First Posted: 2014-05-09
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Arm 1: Simvastatin 40mg / pill, one pill once a day for three months
Placebo pill	Placebo pill	Arm 2: Placebo one pill once a day for three months

Primary Outcome Measures

Name	Time	Method
Hepatic venous pressure gradient (HVPG) in mmHg units	3 months	Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil