Recruitment

Recruitment Status
Completed

Inclusion Criterias

Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.

Exclusion Criterias

Hepatocarcinoma
HIV
Child-Pugh C decompensated or encephalopathy
...
Hepatocarcinoma
HIV
Child-Pugh C decompensated or encephalopathy
Anti-viral therapy
Malignancy except basocellular cancer
Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months

Summary

Conditions
  • Esophageal Varices
  • Liver Cirrhosis
  • Portal Hypertension
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 d...

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.

Inclusion Criterias

Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.

Exclusion Criterias

Hepatocarcinoma
HIV
Child-Pugh C decompensated or encephalopathy
...
Hepatocarcinoma
HIV
Child-Pugh C decompensated or encephalopathy
Anti-viral therapy
Malignancy except basocellular cancer
Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months

Locations

Rio de Janeiro
Rio de Janeiro

Tracking Information

NCT #
NCT02134626
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
  • Principal Investigator: Priscila Pollo-Flores, MD, Master Federal University of Rio de Janeiro - UFRJ
  • Priscila Pollo-Flores, MD, Master Federal University of Rio de Janeiro - UFRJ