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

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changqing Yang
• Collaborators: Fudan University; Nanfang Hospital of Southern Medical University
• Treatments: Carvedilol; Spironolactone

Criteria

Inclusion Criteria:

-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings

Exclusion Criteria:

• Treatment with β-blockers or diuretics in the last 3 months

• Severe cardiopulmonary or renal insufficiency

• Chronic alcohol abuse

• Can't tolerate side effects of oral carvedilol or spironolactone

• History of variceal bleeding

• Malignancy

• Portal vein thrombosis

• History of partial splenic embolization or splenectomy

• Moderate or tense ascites