Portal HypertensionPhase 3NCT02134626
Simvastatin Effect on Portal Hypertension
A Phase 3 study testing Simvastatin in people with Portal Hypertension and Esophageal Varices, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Portal Hypertension, Esophageal Varices, Liver Cirrhosis
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Who cannot join
- Child-Pugh C decompensated or encephalopathy
- Malignancy except basocellular cancer
- Hepatocarcinoma
- Anti-viral therapy
- HIV
- Prevention of digestive hemorrhage with band ligation or sclerotherapy for the last 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
About this study
Official title: Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.
Read the detailed description
The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering resistance that may be responsible for most of cirrhosis complications. Indeed, the potential use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal syndrome are the most harmful consequences of cirrhosis that should be prevented. In that way, simvastatin appears as a promising therapy.The study will include two groups of patients using aleatory randomization and one group will receive simvastatin while the other will receive placebo blindly. At the start and at the end of the study the patients will be submitted to HVPG measurement and azygous vein flow measure.
The endpoints will be the normalization of HVPG or lower significantly(20% or more.
The patients will be followed for 6 months after the end of the study.
- Conditions
- Portal Hypertension, Esophageal Varices, Liver Cirrhosis
- Being tested
- Simvastatin, Placebo pill
- Keywords
- Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG
- Medical subject headings
- Hypertension, Portal, Esophageal and Gastric Varices, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
40mg / pill, one pill orally once a day for three months
Placebo pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Arm 1: Simvastatin 40mg / pill, one pill once a day for three months Receives: Drug: Simvastatin |
| Placebo pill | Placebo comparator | Arm 2: Placebo one pill once a day for three months Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic venous pressure gradient (HVPG) in mmHg units
Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Guilherme Rezende, Universidade Federal do Rio de Janeiro
- Investigators
- Priscila Pollo-Flores, MD, Master, Principal investigator, Federal University of Rio de Janeiro - UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134626
- Sponsor's protocol ID
- simvhp01
- Status last verified
- May 2014
- First submitted
- 4 Apr 2014
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Effect in Portal Hypertension Measured by Portal Hemodynamic Gradient and Azygos Vein Doppler in Echoendoscopy
- ClinicalTrials.gov ID
- NCT02134626
- Acronym / sponsor ID
- simvhp01
- Conditions
- Portal Hypertension, Esophageal Varices, Liver Cirrhosis
- Keywords
- Portal Hypertension, Hepatic Venous Pressure Gradient, Esophageal Varices, Liver Cirrhosis, Simvastatin, Nitric oxide, HVPG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 May 2014 (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.
It´s a clinical research of the effects in portal hypertension caused by simvastatin. We are going to use the hepatic venous pressure gradient(HVPG) measurement and the azygos flow at echoendoscopy to evaluate the benefits of the drug. Preliminary studies demonstrated that simvastatin can lower portal pressure.
Detailed description
The simvastatin can target the liver enhancing nitric oxide intra-hepatic and lowering resistance that may be responsible for most of cirrhosis complications. Indeed, the potential use of this drug may ameliorate the HVPG and azygos flow. Portal hypertension is responsible for most of the cases of death in cirrhosis. The esophageal varices, ascites and hepatorenal syndrome are the most harmful consequences of cirrhosis that should be prevented. In that way, simvastatin appears as a promising therapy.The study will include two groups of patients using aleatory randomization and one group will receive simvastatin while the other will receive placebo blindly. At the start and at the end of the study the patients will be submitted to HVPG measurement and azygous vein flow measure.
The endpoints will be the normalization of HVPG or lower significantly(20% or more.
The patients will be followed for 6 months after the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinArm 1: Simvastatin 40mg / pill, one pill once a day for three months |
| Placebo pill | Placebo comparator | Drug: Placebo pillArm 2: Placebo one pill once a day for three months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Portal hypertension: esophageal varices, ascites, splenomegaly or hepatorenal syndrome.
Key exclusion criteria (6 listed)
- Child-Pugh C decompensated or encephalopathy
- Malignancy except basocellular cancer
- Hepatocarcinoma
- Anti-viral therapy
- HIV
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 |
|---|---|---|
| Simvastatin40mg / pill, one pill orally once a day for three months | Drug | Simvastatin |
| Placebo pill | Drug | Placebo pill |
Primary outcome
Hepatic venous pressure gradient (HVPG) in mmHg units
Time frame: 3 months
Positive results consist of reduction of the HVPG to values equal or less than 12 mmHg or 20% lower than the first measure
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 9 May 2014.
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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.
Priscila Pollo-Flores, MD, Master principal investigator
Federal University of Rio de Janeiro - UFRJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Simvastatin in people with Portal Hypertension and Esophageal Varices, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 1 inclusion and 6 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Hepatic venous pressure gradient (HVPG) in mmHg units (time frame: 3 months). 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 9 May 2014.