NCT02907749

Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis

Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Changqing Yang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.

Conditions

• Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Spironolactone and carvedilol	Patients are treated with carvedilol in combination with spironolactone.
DRUG	Carvedilol	Patients are treated with carvedilol only.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-01-01
• Completion: 2020-07-31
• First posted: 2016-09-20
• Last updated: 2020-08-25

Locations

1 site across 1 country: China