Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine portal pressure. Antiviral therapy may decrease HVPG which needs to be verified.

Study Overview

• Status: Unknown
• Conditions: Portal Hypertension

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Xiaofeng Zhang; Phone Number: +86-18565552050; Email: 1282614092@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis B cirrhosis

Description

Inclusion Criteria:

• Patients with viral cirrhosis were diagnosed;
• Age 18-80 years;
• Need and willing to accept measure HVPG;
• First HVPG measurement of more than 5 mmHg;
• Signed Informed Consent

Exclusion Criteria:

• Patients with viral cirrhosis have been treated with antiviral therapy and have achieved virological response;
• Ready to accept or have accepted a TIPS procedure;
• Splenic embolization was performed;
• Inaccurate measurement of HVPG due to combined hepatic venous shunt;
• Complicated with alcoholic liver disease, autoimmune liver disease or other types of liver disease;
• Complicated with liver cancer or other organ malignancy;
• Combined with severe cardiopulmonary disease affects survival;
• Complicated with severe renal insufficiency;
• Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis;
• Women who are planning to become pregnant or who are pregnant or breastfeeding.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HVPG changed and reached the response standard	HVPG response to therapy indicates a decrease in HVPG of at least 10% from baseline or to less than 12 mmHg after chronic treatment with NSBBs.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antiviral therapy achieved a virological response	HBV-DNA remained undetectable for successive two times.	one year

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 10, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypertension, Portal
• Other Study ID Numbers: NFEC-2021-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No