Carvedilol for Prevention of Esophageal Varices Progression

Last updated: November 29, 2022
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Diabetes And Hypertension

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT03736265
2017ZX10203202003
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);
  • Any contra-indications to beta-blockers including asthma, chronic obstructivepulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heartfailure, 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 varicealligation) or sclerotherapy, history of surgery for portal hypertension includingportosystemic shunts, disconnection and spleen resection and transjugular intrahepaticportosystemic shunt；
  • Severe systemic diseases；
  • Refusal to participate in the study.

Study Design

Total Participants: 240
Study Start date:
October 09, 2017
Estimated Completion Date:
December 30, 2022

Study 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.

Connect with a study center

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing 100015
    China

    Site Not Available

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

  • The First Affiliated Hospital of Shanghai Jiao Tong University

    Shanghai, Shanghai 201620
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.