Portal HypertensionPhase 4NCT02994485
Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
A Phase 4 study testing Simvastatin in people with Portal Hypertension, run by Tanta University at 1 site in Egypt.
Trial summary
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Feb 2018
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
- Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)
Who cannot join
- Pregnancy
- Hepatic encephalopathy grade III-IV
- Hepatocellular carcinoma
- Treatment with statins in the previous 3 months
- Hypersensitivity to statins
- Previous surgical shunt or TIPS
- Treatment with calcium channel blockers
Trial locations and contacts
1 site in 1 country.
About this study
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.
Read the detailed description
Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.
- Conditions
- Portal Hypertension
- Being tested
- Simvastatin
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Corvast
Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Active comparator | Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks Receives: Drug: Simvastatin |
| no treatment | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Reduced Portal Pressure After Intervention
the number of Patients with Reduced Portal Pressure After Intervention
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- NADIA ELWAN, PROFESSOR, Principal investigator, Tanta university hospitalRAAFAT SALAH, PROFESSOR, Study chair, Tanta university hospitalMANAL HAMISA, Ass Prof, Study chair, Tanta university hospitalEBTESAM A SHADY, BACHELOR, Study chair, Tanta University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994485
- Sponsor's protocol ID
- Nadia Elwan
- Status last verified
- Mar 2018
- First submitted
- 13 Dec 2016
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Elwan N, Salah R, Hamisa M, Shady E, Hawash N, Abd-Elsalam S. Evaluation of portal pressure by doppler ultrasound in patients with cirrhosis before and after simvastatin administration - a randomized controlled trial. F1000Res. 2018 Mar 1;7:256. doi: 10.12688/f1000research.13915.1. eCollection 2018.
PubMed 29707200
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin
- ClinicalTrials.gov ID
- NCT02994485
- Acronym / sponsor ID
- Nadia Elwan
- Conditions
- Portal Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Dec 2016 (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.
Portal hypertension is not a disease in itself. Rather, it is an indication of an illness, caused mostly by chronic lesions of the liver because of distinct causes, such as viral infection, chronic alcoholism, or metabolic disorders. Other reasons include splanchnic vascular diseases (for example, obstruction of the portal or the hepatic veins). Portal hypertension is defined as a pressure in the portal vein exceeding the vena cava pressure by more than 5 mm Hg.
Detailed description
Indeed, use of simvastatin might attenuate liver fibrosis in patients with chronic C infection, it may also reduce hepatic vascular resistance and portal pressure by improving liver generation of nitric oxide and hepatic endothelial dysfunction in patients with cirrhosis, so it could be an effective therapy for portal hypertension. It might even improve survival of patients with cirrhosis after variceal bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Active comparator | Drug: SimvastatinSimvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks |
| no treatment | No intervention | –no treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Positive diagnosis of cirrhosis by US (coarse echogenic pattern, bulky caudate lobe, attenuated hepatic veins)
- Clinical manifestations of portal hypertension (as esophageal varices ,splenomegaly, ascites and encephalopathy grade I-II)
Key exclusion criteria (7 listed)
- Pregnancy
- Hepatic encephalopathy grade III-IV
- Hepatocellular carcinoma
- Treatment with statins in the previous 3 months
- Hypersensitivity to statins
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 |
|---|---|---|
| SimvastatinAlso: CorvastSimvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment | Drug | Simvastatin |
Primary outcome
Number of Patients with Reduced Portal Pressure After Intervention
Time frame: 6 Months
the number of Patients with Reduced Portal Pressure After Intervention
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 8 Mar 2018.
- Derived from this study: PubMed 29707200Elwan N, Salah R, Hamisa M, Shady E, Hawash N, Abd-Elsalam S. Evaluation of portal pressure by doppler ultrasound in patients with cirrhosis before and after simvastatin administration - a randomized controlled trial. F1000Res. 2018 Mar 1;7:256. doi: 10.12688/f1000research.13915.1. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
NADIA ELWAN, PROFESSOR principal investigator
Tanta university hospital
RAAFAT SALAH, PROFESSOR study chair
Tanta university hospital
MANAL HAMISA, Ass Prof study chair
Tanta university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Portal Hypertension, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 7 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 8 Mar 2018. 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 Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of Patients with Reduced Portal Pressure After Intervention (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02994485, which also lists 1 linked publication.
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 8 Mar 2018.