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Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

Primary Purpose

Cirrhosis, Portal Hypertension

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis focused on measuring Statins, HMG-CoA reductase inhibitors, Cirrhosis, Portal hypertension, Variceal bleeding

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18 and 75.
  2. Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
  3. Severe sinusoidal portal hypertension (HVPG >12 mmHg)
  4. Signed informed consent

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Advanced liver disease defined as one of the following: Prothrombin rate <40%, Bilirubin >5 mg/dl, hepatic encephalopathy > grade I or Child-Pugh score >12).
  3. Portal vein thrombosis
  4. Multinodular hepatocellular carcinoma or single hepatocellular carcinoma > 5 cm.
  5. Heart, renal or respiratory failure
  6. Previous portal-systemic shunt
  7. Treatment with organic nitrates
  8. Hypersensitivity to HMG-CoA reductase inhibitors
  9. Previous treatment with HMG-CoA reductase inhibitors
  10. Treatment with calcium channel blockers

Sites / Locations

  • Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
  • Servicio de Gastroenterología, Hospital Ramón y Cajal
  • Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

Placebo treatment

Outcomes

Primary Outcome Measures

Changes in hepatic venous pressure gradient (HVPG)

Secondary Outcome Measures

Changes in systemic hemodynamics
Changes in liver function tests

Full Information

First Posted
January 3, 2008
Last Updated
January 3, 2008
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00594191
Brief Title
Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension
Keywords
Statins, HMG-CoA reductase inhibitors, Cirrhosis, Portal hypertension, Variceal bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Arm Title
B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo with the same characteristics of the drug and at the same dose
Primary Outcome Measure Information:
Title
Changes in hepatic venous pressure gradient (HVPG)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in systemic hemodynamics
Time Frame
4 weeks
Title
Changes in liver function tests
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 75. Clinical, analytical, ultrasound or pathological criteria of cirrhosis. Severe sinusoidal portal hypertension (HVPG >12 mmHg) Signed informed consent Exclusion Criteria: Pregnancy or lactation Advanced liver disease defined as one of the following: Prothrombin rate <40%, Bilirubin >5 mg/dl, hepatic encephalopathy > grade I or Child-Pugh score >12). Portal vein thrombosis Multinodular hepatocellular carcinoma or single hepatocellular carcinoma > 5 cm. Heart, renal or respiratory failure Previous portal-systemic shunt Treatment with organic nitrates Hypersensitivity to HMG-CoA reductase inhibitors Previous treatment with HMG-CoA reductase inhibitors Treatment with calcium channel blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Bosch, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Servicio de Gastroenterología, Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28871
Country
Spain
Facility Name
Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón
City
Madrid
Country
Spain

12. IPD Sharing Statement

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Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

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