Portal HypertensionNCT03195634
WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
An observational study of Portal Hypertension and Cirrhosis, run by Shanghai Changzheng Hospital.
Trial summary
Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Portal Hypertension, Cirrhosis
- What is being tested?
- Carvedilol
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Dec 2018
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From June 2017 to March 2018, patients with cirrhosis admitted to either of the two participating hospitals were consecutively enrolled. Hospitals: Shanghai Changzheng hospital and Shandong Provincial Hospital
Who may be able to join
- Patients agreed to sign the informed consents
- Patients aged 18-80 years,males or females
- Patients with liver cirrhosis was diagnosed by previous liver biopsy or by compatible clinical, biochemical, and ultrasonographic/CT/MRI findings.
- Patients were not treated with nonselective β-blockers(propranolol or carvedilol ) within previous 3 months
Who cannot join
- Uncontrolled hypertension, diabetes or other serious cardiac problems（NYHA class IV）and pulmonary disease
- Severe renal function injury(serum creatinine≥1.2 fold of upper limits of normal)
- Conformed or highly suspicious diagnosis of liver malignant tumors or concomitant disease with reduced life expectancy
- Acute hepatic failure or acute on chronic liver failure(ACLF)
- Human immunodeficiency virus(HIV) infection
- Previous portosystemic shunt
Show all 11Show fewer
- After liver transplantation
- Pregnancy and breastfeeding
- With contraindications of intervention surgery(hypersensitivity to iodinated contrast media, puncture site infection, severe coagulation defects, uncontrolled hyperthyroidism and multiple myeloma)
- Participated in other drug clinical trails within 3 months
- The researchers thought it was not suitable for this clinical trail
Trial locations and contacts
No sites are listed yet.
About this study
Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was to explore the relationship between WFA+-M2BP and HVPG.
Read the detailed description
Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. Accurate assessment of portal hypertension is essential for strategy of treatment and judgement of prognosis. Although measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Therefore, it is urgent to explore a noninvasive assessment of portal hypertension.
Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis. Recently, a retrospective study investigated the role of WFA+-M2BP in assessing the degree of liver cirrhosis and predicting mortality. However, the correlation of WFA+-M2BP with HVPG is unclear. And the role of WFA+-M2BP in predicting the clinical outcome of liver fibrosis patients is needed to be further evaluated.
The aim of this study was to explore the relationship between WFA+-M2BP and HVPG, as well as its predictive ability of complication rate, including large varices, bleed status, and ascites, and liver disease-related mortality.
- Conditions
- Portal Hypertension, Cirrhosis
- Being tested
- Carvedilol
- Keywords
- Cirrhosis, Portal Hypertension
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| HVPG group | When HVPG > 12 mmHg, patients would be treated with carvedilol at an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day.
After about 8 weeks, the patients treated with carvedilol will received the second HVPG monitoring wether achieved a decrease in HVPG below 12 mm Hg or>20% from baseline. Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of portal pressure (PP)
portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)
Measured: 3 months
serum WFA+-M2BP levels
serum WFA+-M2BP levels
Measured: 3 months
Secondary outcomes (2)
number of death or liver transplantation
number of death or liver transplantation
Measured: up to 1 year
complications of cirrhosis
large varices, bleed status and ascites
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionDec 2018 (estimated)
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.
- More trials run by Shanghai Changzheng HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Responsible party
- Principal investigator, Wei-Fen Xie, Shanghai Changzheng Hospital
- Investigators
- Wei-Fen Xie, MD, Principal investigator, Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195634
- Sponsor's protocol ID
- CZXH0021
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03195634
- Acronym / sponsor ID
- CZXH0021
- Conditions
- Portal Hypertension, Cirrhosis
- Keywords
- Cirrhosis, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Study start
- Jun 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jun 2017 (actual)
- 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 a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis.However, the correlation of WFA+-M2BP with HVPG is unclear.The aim of this study was to explore the relationship between WFA+-M2BP and HVPG.
Detailed description
Portal hypertension is a common complication of chronic liver diseases and is responsible for most clinical consequences of cirrhosis. Accurate assessment of portal hypertension is essential for strategy of treatment and judgement of prognosis. Although measurement of the hepatic venous pressure gradient(HVPG) is the gold standard for evaluating the presence and severity of portal hypertension, this technique is considered invasive and is not routinely performed in all centers. Therefore, it is urgent to explore a noninvasive assessment of portal hypertension.
Wisteria floribunda agglutinin-positive human Mac-2 binding protein (WFA+-M2BP) is a secreted N-glycoprotein, which has been reported as a novel marker in assessing liver fibrosis. Recently, a retrospective study investigated the role of WFA+-M2BP in assessing the degree of liver cirrhosis and predicting mortality. However, the correlation of WFA+-M2BP with HVPG is unclear. And the role of WFA+-M2BP in predicting the clinical outcome of liver fibrosis patients is needed to be further evaluated.
The aim of this study was to explore the relationship between WFA+-M2BP and HVPG, as well as its predictive ability of complication rate, including large varices, bleed status, and ascites, and liver disease-related mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HVPG group | – | Drug: CarvedilolWhen HVPG > 12 mmHg, patients would be treated with carvedilol at an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day. After about 8 weeks, the patients treated with carvedilol will received the second HVPG monitoring wether achieved a decrease in HVPG below 12 mm Hg or>20% from baseline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From June 2017 to March 2018, patients with cirrhosis admitted to either of the two participating hospitals were consecutively enrolled. Hospitals: Shanghai Changzheng hospital and Shandong Provincial Hospital
Key inclusion criteria (4 listed)
- Patients agreed to sign the informed consents
- Patients aged 18-80 years,males or females
- Patients with liver cirrhosis was diagnosed by previous liver biopsy or by compatible clinical, biochemical, and ultrasonographic/CT/MRI findings.
- Patients were not treated with nonselective β-blockers(propranolol or carvedilol ) within previous 3 months
Key exclusion criteria (11 listed)
- Uncontrolled hypertension, diabetes or other serious cardiac problems（NYHA class IV）and pulmonary disease
- Severe renal function injury(serum creatinine≥1.2 fold of upper limits of normal)
- Conformed or highly suspicious diagnosis of liver malignant tumors or concomitant disease with reduced life expectancy
- Acute hepatic failure or acute on chronic liver failure(ACLF)
- Human immunodeficiency virus(HIV) infection
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 |
|---|---|---|
| Carvedilolan initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day | Drug | HVPG group |
Primary outcome
Changes of portal pressure (PP)
Time frame: 3 months
portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)
serum WFA+-M2BP levels
Time frame: 3 months
serum WFA+-M2BP levels
2 secondary outcomes
number of death or liver transplantation
Time frame: up to 1 year
complications of cirrhosis
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Wei-Fen Xie, MD principal investigator
Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Cirrhosis, run by Shanghai Changzheng Hospital.
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 11 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: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Fen Xie, MD (86-21-81885341, coss2008@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of portal pressure (PP) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 22 Jun 2017.