Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

• Conditions: Portal Hypertension

• Registration Number: NCT04797910
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-07
• Study Start: 2021-03-10
• Study First Submitted QC: 2021-03-11
• Last Update Submitted: 2021-03-11
• Study First Posted: 2021-03-15
• Last Update Posted: 2021-03-15
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HVPG changed and reached the response standard	one year	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.

Secondary Outcome Measures

Name	Time	Method
Antiviral therapy achieved a virological response	one year	HBV-DNA remained undetectable for successive two times.