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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03195634
• Other study ID #: CZXH0021
• Status: Not yet recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: June 21, 2017
• Start date: June 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Shanghai Changzheng Hospital
• Contact: Wei-Fen Xie, MD
• Phone: 86-21-81885341
• Email: coss2008[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Carvedilol
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	Shandong Provincial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of portal pressure (PP)	portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)	3 months
Primary	serum WFA+-M2BP levels	serum WFA+-M2BP levels	3 months
Secondary	number of death or liver transplantation	number of death or liver transplantation	up to 1 year
Secondary	complications of cirrhosis	large varices, bleed status and ascites	up to 1 year