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

Changqing Yang

Status and phase: Completed; Phase 4

Conditions: Portal Hypertension; Cirrhosis

Treatments: Drug: Spironolactone and carvedilol; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT02907749

Yang-20160905

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Carvedilol

Active Comparator group

Description:

Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose

Treatment:

Drug: Spironolactone and carvedilol

Spironolactone and carvedilol

Experimental group

Description:

1. Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose 2. Spironolactone is added after carvedilol being tolerated, which starts with 20mg/d and increases to 40mg/d as a maintainence dose

Treatment:

Drug: Carvedilol