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

NCT ID: NCT03195634

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Portal Hypertension; Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Carvedilol

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei-Fen Xie

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei-Fen Xie, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai

Central Contacts

Wei-Fen Xie, MD

Role: CONTACT

coss2008@yeah.net

86-21-81885341

Other Identifiers

CZXH0021

Identifier Type: -

Identifier Source: org_study_id