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Simvastatin Effect on Portal Hypertension

Primary Purpose

Portal Hypertension, Esophageal Varices, Liver Cirrhosis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Simvastatin
Placebo pill
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 4, 2014
Last Updated
May 7, 2014
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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1. Study Identification

Unique Protocol Identification Number
NCT02134626
Brief Title
Simvastatin Effect on Portal Hypertension
Official Title
Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Esophageal Varices, Liver Cirrhosis
Keywords
Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin
Arm Type
Experimental
Arm Description
Arm 1: Simvastatin 40mg / pill, one pill once a day for three months
Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Arm 2: Placebo one pill once a day for three months
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
40mg / pill, one pill orally once a day for three months
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Primary Outcome Measure Information:
Title
Hepatic venous pressure gradient (HVPG) in mmHg units
Description
Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priscila Pollo-Flores, MD, Master
Organizational Affiliation
Federal University of Rio de Janeiro - UFRJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
Country
Brazil

12. IPD Sharing Statement

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Simvastatin Effect on Portal Hypertension

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