Simvastatin Effect on Portal Hypertension
Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedMay 9, 2014
May 1, 2014
3.7 years
April 4, 2014
May 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Simvastatin
EXPERIMENTALArm 1: Simvastatin 40mg / pill, one pill once a day for three months
Placebo pill
PLACEBO COMPARATORArm 2: Placebo one pill once a day for three months
Interventions
Eligibility Criteria
You may qualify if:
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Priscila Pollo-Flores, MD, Master
Federal University of Rio de Janeiro - UFRJ
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of the Medical Faculty
Study Record Dates
First Submitted
April 4, 2014
First Posted
May 9, 2014
Study Start
August 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-05