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

NCT03195634 | Unknown DMC

• 1 other identifier: CZXH0021
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Portal Hypertension; Cirrhosis

Keywords

Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• Changes of portal pressure (PP)

  portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)

  3 months

• serum WFA+-M2BP levels

  serum WFA+-M2BP levels

  3 months

Secondary Outcomes (2)

• number of death or liver transplantation

  up to 1 year

• complications of cirrhosis

  up to 1 year

Study Arms (1)

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.

Drug: Carvedilol

Interventions

Carvedilol 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

HVPG group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• Shandong Provincial Hospital: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Wei-Fen Xie, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Fen Xie, MD

CONTACT

86-21-81885341; coss2008@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 22, 2017
• Study Start: June 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share