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Phase IV-II Randomized, Multicenter, Placebo-Controlled Double-Blind Clinical Trial Evaluating the Effects of Continuous Simvastatin Administration on Hepatic and Systemic Hemodynamics in Patients With Cirrhosis.
The purpose of this study is to evaluate the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and portal hypertension.
Statins exert beneficial vascular effects independently of cholesterol reduction by improving endothelial dysfunction. In cirrhosis sinusoidal endothelial dysfunction further increases intrahepatic resistance and portal pressure. Previous studies have shown that statins improve hepatic endothelial dysfunction in cirrhosis, suggesting that statins could be an effective therapy for portal hypertension (PHT). This randomized controlled trial evaluated the effects of continuous simvastatin administration on the hepatic venous pressure gradient (HVPG), as a surrogate marker of prognosis, and its safety in patients with cirrhosis and PHT.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, Barcelona, Spain
Servicio de Gastroenterología, Hospital Ramón y Cajal
Madrid, Madrid, Spain
Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón
Madrid, Madrid, Spain
Start Date
March 1, 2004
Primary Completion Date
April 1, 2007
Completion Date
November 1, 2007
Last Updated
January 15, 2008
59
ACTUAL participants
Simvastatin
DRUG
Placebo
DRUG
Lead Sponsor
Hospital Clinic of Barcelona
NCT02417740
NCT05597488
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06932783