The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding

Phase 4

• Conditions: Esophageal and Gastric Varices; Liver Cirrhosis; Hemorrhage
• Interventions: Drug: Carvedilol; Drug: Propranolol

• Registration Number: NCT02385422
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-09
• Last Update Submitted: 2015-03-09
• Study First Posted: 2015-03-11
• Last Update Posted: 2015-03-11
• Primary Completion: 2017-06
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol	Carvedilol	Carvedilol，6.25mg-25mg/d,oral,6 months
Propranolol	Propranolol	Propranolol,30mg-160mg/d,oral,6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse events	6 months	We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia.
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.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China