Simvastatin Effect on Portal Hypertension

NCT ID: NCT02134626

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Portal Hypertension; Esophageal Varices; Liver Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Simvastatin

Arm 1: Simvastatin 40mg / pill, one pill once a day for three months

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Placebo pill

Arm 2: Placebo one pill once a day for three months

Group Type: PLACEBO_COMPARATOR

Placebo pill

Intervention Type: DRUG

Interventions

Simvastatin

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

Intervention Type: DRUG

Placebo pill

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Guilherme Rezende

Associate Professor of the Medical Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priscila Pollo-Flores, MD, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio de Janeiro - UFRJ

Locations

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

simvhp01

Identifier Type: -

Identifier Source: org_study_id