CirrhosisPhase 2NCT00594191
Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension
A Phase 2 study testing Simvastatin in people with Cirrhosis and Portal Hypertension, run by Hospital Clinic of Barcelona at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 3 sitesSpain
- Study dates
- Mar 2004to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75.
- Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
- Severe sinusoidal portal hypertension (HVPG >12 mmHg)
- Signed informed consent
Who cannot join
- 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
Show all 10Show fewer
- Treatment with organic nitrates
- Hypersensitivity to HMG-CoA reductase inhibitors
- Previous treatment with HMG-CoA reductase inhibitors
- Treatment with calcium channel blockers
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, Barcelona, 08036
Servicio de Gastroenterología, Hospital Ramón y Cajal
Madrid, Madrid, 28871
Servicio de Gastroenterología, Hospital Universitario General Gregorio Marañón
Madrid, Madrid
About this study
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.
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.
Read the 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.
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- Simvastatin, Placebo
- Keywords
- Statins, HMG-CoA reductase inhibitors, Cirrhosis, Portal hypertension, Variceal bleeding
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met
PlaceboDrug
Placebo with the same characteristics of the drug and at the same dose
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo treatment Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatic venous pressure gradient (HVPG)
Measured: 4 weeks
Secondary outcomes (2)
Changes in systemic hemodynamics
Measured: 4 weeks
Changes in liver function tests
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMar 2004
- Primary completionApr 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Jaime Bosch, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594191
- Sponsor's protocol ID
- SIMV-HTP2003
- Other IDs
- AEM 03-0434
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00594191
- Acronym / sponsor ID
- SIMV-HTP2003
- Conditions
- Cirrhosis, Portal Hypertension
- Keywords
- Statins, HMG-CoA reductase inhibitors, Cirrhosis, Portal hypertension, Variceal bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo treatment |
| B | Experimental | Drug: Simvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75.
- Clinical, analytical, ultrasound or pathological criteria of cirrhosis.
- Severe sinusoidal portal hypertension (HVPG >12 mmHg)
- Signed informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin20 mg/day p.o., increased to 40 mg/day at day 15 if no safety end-point was met | Drug | B |
| PlaceboPlacebo with the same characteristics of the drug and at the same dose | Drug | A |
Primary outcome
Changes in hepatic venous pressure gradient (HVPG)
Time frame: 4 weeks
2 secondary outcomes
Changes in systemic hemodynamics
Time frame: 4 weeks
Changes in liver function tests
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Bosch, MD principal investigator
Hospital Clinic of Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Cirrhosis and Portal Hypertension, run by Hospital Clinic of Barcelona at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hepatic venous pressure gradient (HVPG) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.