Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195634
Recruitment Status : Unknown
Verified June 2017 by Wei-Fen Xie, Shanghai Changzheng Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Shandong Provincial Hospital
Information provided by (Responsible Party):
Wei-Fen Xie, 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.

Condition or disease Intervention/treatment
Portal Hypertension Cirrhosis Drug: Carvedilol

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Changes of portal pressure (PP) [ Time Frame: 3 months ]
    portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)

  2. serum WFA+-M2BP levels [ Time Frame: 3 months ]
    serum WFA+-M2BP levels


Secondary Outcome Measures :
  1. number of death or liver transplantation [ Time Frame: up to 1 year ]
    number of death or liver transplantation

  2. complications of cirrhosis [ Time Frame: up to 1 year ]
    large varices, bleed status and ascites


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195634


Contacts
Layout table for location contacts
Contact: Wei-Fen Xie, MD 86-21-81885341 coss2008@yeah.net

Sponsors and Collaborators
Shanghai Changzheng Hospital
Shandong Provincial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wei-Fen Xie, MD Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai

Layout table for additonal information
Responsible Party: Wei-Fen Xie, Director, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03195634     History of Changes
Other Study ID Numbers: CZXH0021
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei-Fen Xie, Shanghai Changzheng Hospital:
Cirrhosis
Portal Hypertension
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists