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

Phase 4

Completed

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Drug: Carvedilol; Drug: Spironolactone and carvedilol

• Registration Number: NCT02907749
• Lead Sponsor: Changqing Yang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Study Start: 2018-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-21
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spironolactone and carvedilol	Carvedilol	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
Carvedilol	Spironolactone and carvedilol	Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose

Primary Outcome Measures

Name	Time	Method
Virtual portal pressure gradient(vPPG)	6 months	Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
Liver stiffness measurement (LSM)	6 months	Detected using FibroScan
Occurence of portal hypertension-related complications	6 months	variceal bleeding, ascites, hepatic encephalopathy

Trial Locations

Locations (1)

Shanghai Tongji Hospital, Tongji University; 🇨🇳 Shanghai, Shanghai, China