Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04797910

Enrollment

Registered

2021-03-15

Start date

2021-03-10

Completion date

2022-12-31

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Portal Hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary ContactXiaofeng Zhang

1282614092@qq.com+86-18565552050

Outcome results