Esophageal Varices, Liver Cirrhosis, Portal Hypertension
Conditions
Keywords
Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG
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.
Interventions
DRUGSimvastatin
40mg / pill, one pill orally once a day for three months
DRUGPlacebo pill
Sponsors
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Universidade Federal do Rio de Janeiro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic venous pressure gradient (HVPG) in mmHg units | 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 |
Countries
Brazil
Outcome results
None listed