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Simvastatin Effect on Portal Hypertension

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ClinicalTrials.gov Identifier: NCT02134626
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Guilherme Rezende, Universidade Federal do Rio de Janeiro

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.

Condition or disease Intervention/treatment Phase
Portal Hypertension Esophageal Varices Liver Cirrhosis Drug: Simvastatin Drug: Placebo pill Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
Study Start Date : August 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Experimental: Simvastatin
Arm 1: Simvastatin 40mg / pill, one pill once a day for three months
Drug: Simvastatin
40mg / pill, one pill orally once a day for three months

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



Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134626


Locations
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Brazil
Federal University of Rio de Janeiro
Rio de Janeiro, Brazil
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
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Principal Investigator: Priscila Pollo-Flores, MD, Master Federal University of Rio de Janeiro - UFRJ

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Responsible Party: Guilherme Rezende, Associate Professor of the Medical Faculty, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02134626     History of Changes
Other Study ID Numbers: simvhp01
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Keywords provided by Guilherme Rezende, Universidade Federal do Rio de Janeiro:
Portal Hypertension
Hepatic Venous Pressure Gradient
Esophageal Varices
Liver Cirrhosis
Simvastatin
Nitric oxide
HVPG
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors