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Status unknownNCT02385422Updated Mar 11, 2015

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

A Phase 4 interventional study of Carvedilol and Propranolol in Liver Cirrhosis, Esophageal and Gastric Varices and Hemorrhage, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-11.

Sponsored by Shanghai Zhongshan Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cirrhosis
  • Esophageal and Gastric Varices
  • Hemorrhage

Keywords

  • secondary prophylaxis
  • Propranolol
  • Carvedilol
  • comparative effectiveness research
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 480 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    Carvedilol

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

    Drug: Carvedilol

  • Active comparator
    Propranolol

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

    Drug: Propranolol

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.

    Also known as: JinLuo

  • 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.

    Also known as: XinDeAn

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Rebleeding rate

    We observe the variceal rebleeding events during 6 months.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. Adverse events

    We observe any severe adverse events caused by drug treatment,including palpitation,bronchospasm,syncope,dizziness,hypotension,ascites,edema,bradycardia.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Zhongshan Hospital
    Shanghai, Shanghai 200032, China
    • Yichao Wei, Doctor · Contact · 08301010253@fudan.edu.cn · 86-13918891342
    • Shiyao Chen, Professor · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02385422
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Shiyao Chen (Director of department of Gastroenterology, Zhongshan Hospital, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Mar 11, 2015
Start date
Mar 2015
Primary completion
Jun 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Mar 11, 2015

Study contacts

Shiyao Chen, Professor
Contact
chen.shiyao@zs-hospital.sh.cn
86-13601767310
Shiyao Chen, Professor
study director · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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