Simvastatin Effect on Portal Hypertension

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134626
• Other study ID #: simvhp01
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2014
• Last updated: May 7, 2014
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Varices
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Simvastatin
40mg / pill, one pill orally once a day for three months
• Placebo pill

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes