Simvastatin Effect on Portal Hypertension

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02134626
Study type	Interventional
Source	Universidade Federal do Rio de Janeiro
Contact
Status	Completed
Phase	Phase 3
Start date	August 2010
Completion date	April 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04533932` - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting	`NCT06031740` - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids	N/A
Not yet recruiting	`NCT06026267` - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis	N/A
Not yet recruiting	`NCT06076330` - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension	N/A
Enrolling by invitation	`NCT05055713` - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism	N/A
Recruiting	`NCT04578301` - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting	`NCT05120557` - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH	N/A
Not yet recruiting	`NCT05515861` - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices	N/A
Not yet recruiting	`NCT02710227` - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis	N/A
Not yet recruiting	`NCT03623360` - Functional MRI to Determine Severity of Cirrhosis
Completed	`NCT02917408` - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting	`NCT02551250` - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting	`NCT02239991` - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant	N/A
Enrolling by invitation	`NCT02256514` - Open Label Trial of Immunotherapy for Advanced Liver Cancer	Phase 2
Terminated	`NCT02311985` - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial	N/A
Terminated	`NCT01937130` - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF	Phase 2
Recruiting	`NCT01724697` - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2
Recruiting	`NCT01728688` - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2
Recruiting	`NCT01618890` - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding	Phase 3
Recruiting	`NCT01728727` - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis	Phase 1/Phase 2