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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol | Active Comparator | Carvedilol starts at 6.25mg/d and increases to 12.5mg/d in next week as a maintainence dose |
|
| Spironolactone and carvedilol | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone and carvedilol | Drug | Patients are treated with carvedilol in combination with spironolactone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver stiffness measurement (LSM) | Detected using FibroScan | 6 months |
| Occurence of portal hypertension-related complications | variceal bleeding, ascites, hepatic encephalopathy |
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Inclusion Criteria:
-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Li, M.D. | Shanghai Tongji Hospital, Tongji University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital, Tongji University | Shanghai | Shanghai Municipality | 20065 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D000077261 | Carvedilol |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Carvedilol | Drug | Patients are treated with carvedilol only. |
|
|
| 6 months |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |