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

Primary Purpose

Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Carvedilol
Propranolol
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Cirrhosis focused on measuring secondary prophylaxis, Propranolol, Carvedilol, comparative effectiveness research

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol

Propranolol

Arm Description

Carvedilol，6.25mg-25mg/d,oral,6 months

Propranolol,30mg-160mg/d,oral,6 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rebleeding rate
We observe the variceal rebleeding events during 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.
Adverse events
We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia.

Full Information

First Posted
March 4, 2015
Last Updated
March 9, 2015
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02385422
Brief Title
The Effect of Carvedilol Vs Propranolol in Cirrhotic Patients With Variceal Bleeding
Official Title
The Effect of Carvedilol Vs Propranolol in Patients With Cirrhosis Related Esophagogastric Varices After Multiple Endoscopic Treatments For Secondary Prophylaxis:A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Esophageal and Gastric Varices, Hemorrhage
Keywords
secondary prophylaxis, Propranolol, Carvedilol, comparative effectiveness research

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Carvedilol，6.25mg-25mg/d,oral,6 months
Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
Propranolol,30mg-160mg/d,oral,6 months
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
JinLuo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propranolol
Other Intervention Name(s)
XinDeAn
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endoscopic Retreatment
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rebleeding rate
Description
We observe the variceal rebleeding events during 6 months.
Time Frame
6 months
Title
Mortality rate
Description
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.
Time Frame
6 months
Title
Adverse events
Description
We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyao Chen, Professor
Phone
86-13601767310
Email
chen.shiyao@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yichao Wei, Doctor
Phone
86-13918891342
Email
08301010253@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiyao Chen, Professor

12. IPD Sharing Statement

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

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