WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Drug: Carvedilol

• Registration Number: NCT03195634
• Lead Sponsor: Shanghai Changzheng Hospital

Brief 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 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 Timeline

• Status Verified: 2017-06
• Study Start: 2017-06
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Primary Completion: 2018-03
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients agreed to sign the informed consents
2. Patients aged 18-80 years,males or females
3. Patients with liver cirrhosis was diagnosed by previous liver biopsy or by compatible clinical, biochemical, and ultrasonographic/CT/MRI findings.
4. Patients were not treated with nonselective β-blockers(propranolol or carvedilol ) within previous 3 months

Exclusion Criteria

1. Uncontrolled hypertension, diabetes or other serious cardiac problems（NYHA class IV）and pulmonary disease
2. Severe renal function injury(serum creatinine≥1.2 fold of upper limits of normal)
3. Conformed or highly suspicious diagnosis of liver malignant tumors or concomitant disease with reduced life expectancy
4. Acute hepatic failure or acute on chronic liver failure(ACLF)
5. Human immunodeficiency virus(HIV) infection
6. Previous portosystemic shunt
7. After liver transplantation
8. Pregnancy and breastfeeding
9. With contraindications of intervention surgery(hypersensitivity to iodinated contrast media, puncture site infection, severe coagulation defects, uncontrolled hyperthyroidism and multiple myeloma)
10. Participated in other drug clinical trails within 3 months
11. The researchers thought it was not suitable for this clinical trail

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HVPG group	Carvedilol	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.

Primary Outcome Measures

Name	Time	Method
serum WFA+-M2BP levels	3 months	serum WFA+-M2BP levels
Changes of portal pressure (PP)	3 months	portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)

Secondary Outcome Measures

Name	Time	Method
complications of cirrhosis	up to 1 year	large varices, bleed status and ascites
number of death or liver transplantation	up to 1 year	number of death or liver transplantation