The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH

Portal Hypertension Clinical Trial

Official title:

The Effect of Monitoring Portal Venous Pressure on Clinical Outcomes in Patients With Portal Hypertension: a Prospective, Single-center, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04820166
• Other study ID #: NFEC-2021-062
• Status: Recruiting
• Start date: March 12, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaofeng Zhang
• Phone: +8618565552050
• Email: 1282614092[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. The level of portal venous pressure is closely related to the prognosis of patients. HVPG (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of NSBBS. However, monitoring HVPG has many limitations，and the clinical application is also limited to a certain extent. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. Therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. At the same time, to explore the correlation between HVPG and PPG in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• With chronic liver disease
• Age 18-80 years
• Patients who require a portal pressure measurement at the discretion of the treating physician
• Voluntarily signed informed consent

Exclusion Criteria:

• With serious cardiopulmonary disease or other diseases affect survival
• With severe renal dysfunction
• Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis
• Women who are planning to become pregnant or who are pregnant or breastfeeding
• The researcher judged that it was not suitable to participate in this study

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Other:
• monitoring portal pressure gradient or hepatic venous pressure gradient
measuring portal pressure gradient or hepatic venous pressure gradient regularly

Locations

Country	Name	City	State
China	Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroesophageal varices bleeding	Patients with gastroesophageal varices has hematemesis or melena, and active bleeding or red sign can be seen under endoscopy	three years
Primary	Ascites	Peritoneal effusion was seen under ultrasound	three years
Primary	Hepatic encephalopathy	Patients with altered consciousness or unresponsiveness, accompanied by elevated blood ammonia	three years
Secondary	Death or final follow-up time (3 years)		three years