Carvedilol for Prevention of Esophageal Varices Progression

Capital Medical University

Status: Active, not recruiting

Conditions: Portal Hypertension; Cirrhosis, Liver

Treatments: Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT03736265

2017ZX10203202003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Carvedilol+ Nucleos(t)ide Analogues

Experimental group

Description:

Based on nucleoside analogue (NUCs), carvedilol will added to the patients. 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.

Treatment:

Drug: Carvedilol

Nucleos(t)ide Analogues

No Intervention group

Description:

Continuing take nucleoside analogue (NUCs) including lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (TBV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF).