A Phase 4 interventional study of Spironolactone and carvedilol and Carvedilol in Cirrhosis and Portal Hypertension, sponsored by Changqing Yang. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-08-25.
Sponsored by Changqing Yang · Phase 4, Interventional, and Prevention
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 96 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Changqing Yang is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
Exclusion Criteria:
Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose
Drug: Spironolactone and 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
Drug: Carvedilol
Patients are treated with carvedilol in combination with spironolactone.
Also known as: Combination therapy
Patients are treated with carvedilol only.
Also known as: Single therapy
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
Time frame: 6 months
Liver stiffness measurement (LSM)
Detected using FibroScan
Time frame: 6 months
Occurence of portal hypertension-related complications
variceal bleeding, ascites, hepatic encephalopathy
Time frame: 6 months
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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