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
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension Esophageal Varices Liver Cirrhosis||Drug: Simvastatin Drug: Placebo pill||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 1: Simvastatin 40mg / pill, one pill once a day for three months
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
- 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
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
|Federal University of Rio de Janeiro|
|Rio de Janeiro, Brazil|
|Principal Investigator:||Priscila Pollo-Flores, MD, Master||Federal University of Rio de Janeiro - UFRJ|