Carvedilol for Prevention of Esophageal Varices Progression

Portal Hypertension Clinical Trial

— Carvedilol  

Official title:

Clinical Study of Carvedilol for the Prevention of the Progression of Esophageal Varices in Hepatitis B Related Cirrhotic Patients With Anti-Viral Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736265
• Other study ID #: 2017ZX10203202003
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.

Description:

It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or Female;

• HBV-related liver cirrhotic patients with at least two years of antiviral therapy;

• The presence of small or medium esophageal varices without red color sign;

• HBV-DNA<1×10E3 IU/ml

• Signature of informed consent

Exclusion Criteria:

• Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);

• Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR < 50 bpm), cardiogenic shock, hypotension (SBP < 90 mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease.

• Allergic to Carvedilol;

• Any malignancy that affects survival;

• Renal dysfunction;

• History of beta-blockers within last 3 months;

• History of surgery for portal hypertension;History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt;

• Severe systemic diseases;

• Refusal to participate in the study.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Esophageal and Gastric Varices
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Carvedilol
Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The progression Incidence of esophageal varices.	Progression of esophageal varices defines as follows: Varices developed from small(F1) to medium or large(F2/F3); Varices developed from medium(F2) to large(F3); Bleeding from esophageal varices.	2 years
Secondary	The incidence of liver cirrhosis decompensation	Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy) after 2 year.	2 years
Secondary	The incidence of hepatic cellular carcinoma, death or liver transplantation.	Cumulative rate of hepatic cellular carcinoma, death or liver transplantation after 2 year.	2 years
Secondary	The progression rate of non-invasive scores (Child-Pugh?MELD?APRI?FIB-4 score).	The progression rate of Child-Pugh?MELD?APRI?FIB-4 score after 2 years.	2 years
Secondary	The dynamic change of liver stiffness quantified by transient elastography.	The dynamic change of liver stiffness quantified by transient elastography after 2 years.	2 years
Secondary	The dynamic change of hemodynamics parameter	The dynamic change of hemodynamics (HR and mean arterial pressure) after 2 years.	2 years