Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Portal Hypertension Clinical Trial

Official title:

Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04797910
• Other study ID #: NFEC-2021-002
• Status: Not yet recruiting
• Start date: March 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xiaofeng Zhang
• Phone: +86-18565552050
• Email: 1282614092[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension, Portal
• Portal Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antiviral therapy achieved a virological response	HBV-DNA remained undetectable for successive two times.	one year