Study About Simvastatin in Portal Hypertension in Compensated Cirrhosis
SIMPRO
Prevention of Progression of Portal Hypertension in Compensated Cirrhosis Using Selective Hepatic Vasodilators. A Double-blind, Multicenter,Randomized Controlled Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to determine whether simvastatin is effective in the prevention of progression of porta hypertension in compensated cirrhosis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 25, 2011
January 1, 2011
1 year
January 21, 2011
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
the treatment of portal hypertension with simvastatin may prevent progression of portal hypertension
The main objective is to assess whether, in patients with compensated cirrhosis and mild portal hypertension (GPP between 6 and 10mmHg), the treatment of portal hypertension with simvastatin may prevent progression of portal hypertension and prevent the development of clinically significant HTP (defined GPP by a ≥ 10 mmHg)
4 years
Secondary Outcomes (2)
Portal hypertension complications
four years
Adverse effects
four years
Study Arms (2)
simvastatin
EXPERIMENTALThe experimental group will take simvastatin 40mg for at least two years.
placebo
PLACEBO COMPARATORthe control group wiil take placebo pills for at least two years.
Interventions
The experimental group will take 40 mg each 24 hours for at least two years.
Eligibility Criteria
You may qualify if:
- Liver cirrhosis diagnosed by previous biopsy or by clinical, laboratory, ultrasound
- Portal hypertension gradient between6 mmHg and10 mmHg
- Absence of esophageal and gastric varices or small esophageal varices without red signs
- Absence previous episodes of gastrointestinal hemorrhage, ascites, encephalopathy or jaundice
- Written informed consent
You may not qualify if:
- Age \<18 and\> 80 years,
- Presence or history of ascites, clinical or ultrasound,
- Previous decompensation of liver cirrhosis, ascites or SBP, bleeding varices, large varices, hepatic encephalopathy, jaundice,
- Thrombosis splenoportal,
- Hepatocellular carcinoma;
- Child-Pugh \>7 point
- Any comorbidity that leads to a restriction therapy and / or a life expectancy \<12 months
- Absolute contraindication to treatment with statins or allergy Simvastatin;
- Concomitant potent CYP3A4 inhibitors (eg., itraconazole, ketoconazole, protease inhibitors, HIV, erythromycin, clarithromycin, telithromycin and nefazodone),
- Pretreatment (\<1 month) with simvastatin or other lipid-lowering,
- Previous episodes of rhabdomyolysis,
- Active alcoholic hepatitis,
- Refusal to participate in the study or the informed consent claim;
- Pre-treatment with beta blockers or nitrates, or endoscopic treatment for varicose veins or portosystemic derivations;
- Pregnancy and lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Related Publications (5)
Abraldes JG, Albillos A, Banares R, Turnes J, Gonzalez R, Garcia-Pagan JC, Bosch J. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology. 2009 May;136(5):1651-8. doi: 10.1053/j.gastro.2009.01.043. Epub 2009 Jan 24.
PMID: 19208350RESULTGroszmann RJ, Garcia-Tsao G, Bosch J, Grace ND, Burroughs AK, Planas R, Escorsell A, Garcia-Pagan JC, Patch D, Matloff DS, Gao H, Makuch R; Portal Hypertension Collaborative Group. Beta-blockers to prevent gastroesophageal varices in patients with cirrhosis. N Engl J Med. 2005 Nov 24;353(21):2254-61. doi: 10.1056/NEJMoa044456.
PMID: 16306522RESULTVillanueva C, Aracil C, Colomo A, Hernandez-Gea V, Lopez-Balaguer JM, Alvarez-Urturi C, Torras X, Balanzo J, Guarner C. Acute hemodynamic response to beta-blockers and prediction of long-term outcome in primary prophylaxis of variceal bleeding. Gastroenterology. 2009 Jul;137(1):119-28. doi: 10.1053/j.gastro.2009.03.048. Epub 2009 Apr 1.
PMID: 19344721RESULTZafra C, Abraldes JG, Turnes J, Berzigotti A, Fernandez M, Garca-Pagan JC, Rodes J, Bosch J. Simvastatin enhances hepatic nitric oxide production and decreases the hepatic vascular tone in patients with cirrhosis. Gastroenterology. 2004 Mar;126(3):749-55. doi: 10.1053/j.gastro.2003.12.007.
PMID: 14988829RESULTMarrache MK, Rockey DC. Statins for treatment of chronic liver disease. Curr Opin Gastroenterol. 2021 May 1;37(3):200-207. doi: 10.1097/MOG.0000000000000716.
PMID: 33654016DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candido Villanueva, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 21, 2011
First Posted
January 25, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2015
Last Updated
January 25, 2011
Record last verified: 2011-01