Simvastatin Effect on Portal Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Portal Hypertension; Esophageal Varices
• Intervention / Treatment: Drug: Simvastatin; Drug: Placebo pill

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil
    • Federal University of Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simvastatin; Arm 1: Simvastatin 40mg / pill, one pill once a day for three months	Drug: Simvastatin; 40mg / pill, one pill orally once a day for three months
Placebo Comparator: Placebo pill; Arm 2: Placebo one pill once a day for three months	Drug: Placebo pill

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
• Investigators: Principal Investigator: Priscila Pollo-Flores, MD, Master, Federal University of Rio de Janeiro - UFRJ

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Nitric oxide; Simvastatin; HVPG; Portal Hypertension; Esophageal Varices; Hepatic Venous Pressure Gradient
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Fibrosis; Hypertension; Liver Cirrhosis; Esophageal and Gastric Varices; Hypertension, Portal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: simvhp01