Skip to main content
OpenTrials
Completed

NCT Number: NCT02134626

Simvastatin Effect on Portal Hypertension

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Portal Hypertension Digestive System Diseases Esophageal Diseases Esophageal Varices Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Rio de Janeiro

Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simvastatin

Drug

40mg / pill, one pill orally once a day for three months

Placebo pill

Drug

Primary outcomes

  1. Hepatic venous pressure gradient (HVPG) in mmHg units

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.