Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

NCT04797910 | Unknown

• 1 other identifier: NFEC-2021-002
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Antiviral therapy achieved a virological response

  one year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis B cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Xiaofeng Zhang

CONTACT

+86-18565552050; 1282614092@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 15, 2021
• Study Start: March 10, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share