WFA+M2BP in Evaluation of Portal Hypertension and Clinical Outcome in Patients With Liver Cirrhosis
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|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
|Condition or disease||Intervention/treatment|
|Portal Hypertension Cirrhosis||Drug: Carvedilol|
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 Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
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.
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
- Changes of portal pressure (PP) [ Time Frame: 3 months ]portal pressure (PP) will be estimated from the hepatic venous pressure gradient(HVPG)
- serum WFA+-M2BP levels [ Time Frame: 3 months ]serum WFA+-M2BP levels
- number of death or liver transplantation [ Time Frame: up to 1 year ]number of death or liver transplantation
- complications of cirrhosis [ Time Frame: up to 1 year ]large varices, bleed status and ascites
Biospecimen Retention: Samples Without DNA
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
|Contact: Wei-Fen Xie, MDemail@example.com|
|Principal Investigator:||Wei-Fen Xie, MD||Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai|