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

Cirrhosis Clinical Trial

— FP-PH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907749
• Other study ID #: Yang-20160905
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Treatment with ß-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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Spironolactone and carvedilol
Patients are treated with carvedilol in combination with spironolactone.
• Carvedilol
Patients are treated with carvedilol only.

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changqing Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virtual portal pressure gradient(vPPG)	Calculated based on reconstructed 3D portal trunk using anatomical information extracted from CT angiography and blood flow velocity measured by Doppler ultrasound	6 months
Secondary	Liver stiffness measurement (LSM)	Detected using FibroScan	6 months
Secondary	Occurence of portal hypertension-related complications	variceal bleeding, ascites, hepatic encephalopathy	6 months