Simvastatin Effect on Portal Hypertension
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Exclusion Criteria
- Child-Pugh C decompensated or encephalopathy
- Anti-viral therapy
- Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
- ...
- Child-Pugh C decompensated or encephalopathy
- Anti-viral therapy
- Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
- Malignancy except basocellular cancer
- Hepatocarcinoma
- HIV
Summary
- Conditions
- Esophageal Varices
- Liver Cirrhosis
- Portal Hypertension
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 d...
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.
Inclusion Criteria
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Exclusion Criteria
- Child-Pugh C decompensated or encephalopathy
- Anti-viral therapy
- Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
- ...
- Child-Pugh C decompensated or encephalopathy
- Anti-viral therapy
- Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
- Malignancy except basocellular cancer
- Hepatocarcinoma
- HIV
Tracking Information
- NCT #
- NCT02134626
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Investigators
- Principal Investigator: Priscila Pollo-Flores, MD, Master Federal University of Rio de Janeiro - UFRJ
- Priscila Pollo-Flores, MD, Master Federal University of Rio de Janeiro - UFRJ
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