Carvedilol for Prevention of Esophageal Varices Progression
- Registration Number
- NCT03736265
- Lead Sponsor
- Beijing Friendship Hospital
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carvedilol+ Nucleos(t)ide Analogues Carvedilol 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.
- Primary Outcome Measures
Name Time Method The progression Incidence of esophageal varices. 2 years Progression of esophageal varices defines as follows:
1. Varices developed from small(F1) to medium or large(F2/F3)
2. Varices developed from medium(F2) to large(F3)
3. Bleeding from esophageal varices.
- Secondary Outcome Measures
Name Time Method The incidence of liver cirrhosis decompensation 2 years Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy) after 2 year.
The incidence of hepatic cellular carcinoma, death or liver transplantation. 2 years Cumulative rate of hepatic cellular carcinoma, death or liver transplantation after 2 year.
The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score). 2 years The progression rate of Child-Pugh、MELD、APRI、FIB-4 score after 2 years.
The dynamic change of liver stiffness quantified by transient elastography. 2 years The dynamic change of liver stiffness quantified by transient elastography after 2 years.
The dynamic change of hemodynamics parameter 2 years The dynamic change of hemodynamics (HR and mean arterial pressure) after 2 years.
Trial Locations
- Locations (6)
Beijing Ditan Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China