Esophageal and Gastric Varices, Hemorrhage, Liver Cirrhosis
Conditions
Keywords
secondary prophylaxis, Propranolol, Carvedilol, comparative effectiveness research
Brief summary
To compare the efficacy and safety of Carvedilol and Propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.
Detailed description
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.
Interventions
DRUGCarvedilol
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.
DRUGPropranolol
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age between 18-70 years old; * cirrhotic patients referred to Zhongshan Hospital with esophagogastric varices confirmed by endoscopy; * history of variceal bleeding; at least 3 times of endoscopic treatment; * with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting.
Exclusion criteria
Patients are excluded when they have * episodes of variceal bleeding after the last endoscopic treatment; * diagnosis of hepatic cellular carcinoma; * severe systemic diseases; * refractory ascites; * contraindication to Carvedilol or Propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, New York Heart Association IV chronic heart failure, atrioventricular blockade, severe bradycardia(HR\<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(ABPsys\<85mmHg); * previous and continued use of β-blockers; * Child -Pugh Class C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Retreatment | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate | 6 months | We observe the variceal rebleeding events during 6 months. |
| Mortality rate | 6 months | 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. |
| Adverse events | 6 months | We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia. |
Countries
China
Contacts
Primary ContactShiyao Chen, Professor
Outcome results
None listed