NCT00594191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

Enrollment Period

3.1 years

First QC Date

January 3, 2008

Last Update Submit

January 3, 2008

Conditions

CirrhosisPortal Hypertension

Keywords

StatinsHMG-CoA reductase inhibitorsCirrhosisPortal hypertensionVariceal bleeding

Outcome Measures

Primary Outcomes (1)

  • Changes in hepatic venous pressure gradient (HVPG)

    4 weeks

Secondary Outcomes (2)

  • Changes in systemic hemodynamics

    4 weeks

  • Changes in liver function tests

    4 weeks

Study Arms (2)

A

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

B

EXPERIMENTAL
Drug: Simvastatin

Interventions

SimvastatinDRUG

20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met

B
PlaceboDRUG

Placebo with the same characteristics of the drug and at the same dose

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.

Barcelona, Barcelona, 08036, Spain

Location

Servicio de Gastroenterología, Hospital Ramón y Cajal

Madrid, Madrid, 28871, Spain

Location

Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

FibrosisHypertension, Portal

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jaime Bosch, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

March 1, 2004

Primary Completion

April 1, 2007

Study Completion

November 1, 2007

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

ES(3)