Carvedilol for Prevention of Esophageal Varices Progression (Carvedilol)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    240
  • sponsor
    Beijing Friendship Hospital
Updated on 24 March 2022
hypertension
hepatitis
carvedilol
antiviral drugs
propranolol
esophageal varices
varicose veins

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.

Details
Condition Cirrhosis, Liver, Portal Hypertension
Treatment Carvedilol
Clinical Study IdentifierNCT03736265
SponsorBeijing Friendship Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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