drugset / Trial / NCT02907749

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

NCT02907749

Phase 4 Completed 96 enrolled Changqing Yang
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2018-01-01
Primary completion
2020-01-01
Completion
2020-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Spironolactone Small molecule 40 mg
Background Carvedilol Other / unclassified 12.5 mg