Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.
The study is a randomized controlled trial. Patients randomly enter into two treatment groups: 1)the Carvedilol group and 2)the Propranolol group. Treatment allocation is by block randomization, with an equal number for Carvedilol and Propranolol. The results are concealed in opaque envelopes. The dose of non-selective β-blocker(NSBB) is titrated according to systolic arterial blood pressure (ABPsys) and heart rate (HR). Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Patients receiving propranolol start at a dose of 30 mg/day and the dose will be increased to a maximum dose of 160 mg/day. Patients will be followed up with telephone calls every 2 months. After taking these 2 drugs for 6 months, patients come for clinic visits, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol | Experimental | Carvedilol，6.25mg-25mg/d,oral,6 months |
|
| Propranolol | Active Comparator | Propranolol,30mg-160mg/d,oral,6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Retreatment | Patients will receive an endoscopic examination after they have been followed up for 6 months, and if they have recurrence of varices or deterioration of varices,they are considered to be in need of endoscopic retreatment. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate | We observe the variceal rebleeding events during 6 months. | 6 months |
| Mortality rate | We observe the mortality events during 6 months due to variceal bleeding, hepatic encephalopathy, liver failure, hepatic cellular carcinoma, hepatic-renal syndrome and spontaneous bacterial peritonitis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients are excluded when they have
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyao Chen, Professor | Contact | 86-13601767310 | chen.shiyao@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shiyao Chen, Professor | Shanghai Zhongshan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D004932 | Esophageal and Gastric Varices |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Propranolol | Drug | Patients receiving propranolol start at a dose of 30 mg/d and the dose will be increased to a maximum dose of 160 mg/d.Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm. |
|
|
| 6 months |
| Adverse events | We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia. | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006975 | Hypertension, Portal |
| 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 |
| D050198 | Phenoxypropanolamines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |