Carvedilol for Prevention of Esophageal Varices Progression

NCT03736265 | Unknown DMC

• 1 other identifier: 2017ZX10203202003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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.

Conditions

Cirrhosis, Liver; Portal Hypertension

Keywords

Portal Hypertension; Esophageal varices; Carvedilol

Outcome Measures

Primary Outcomes (1)

• The progression Incidence of esophageal varices.

  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.

  2 years

Secondary Outcomes (5)

• The incidence of liver cirrhosis decompensation

  2 years

• The incidence of hepatic cellular carcinoma, death or liver transplantation.

  2 years

• The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score).

  2 years

• The dynamic change of liver stiffness quantified by transient elastography.

  2 years

• The dynamic change of hemodynamics parameter

  2 years

Study Arms (2)

Carvedilol+ Nucleos(t)ide Analogues

EXPERIMENTAL

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.

Drug: Carvedilol

Nucleos(t)ide Analogues

NO INTERVENTION

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

Interventions

Carvedilol DRUG

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.

Also known as: Nucleos(t)ide Analogues

Carvedilol+ Nucleos(t)ide Analogues

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (6)

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 201620, China

Location

Related Publications (1)

• Wang B, Zhou J, Wu X, Sun Y, Li L, Li P, Li M, Jiang W, Xu M, Feng B, Xu X, Cheng J, Xie W, Han T, Wang X, Li H, Piao H, Zhao X, Chen S, Meng T, Guan Q, Meng F, Kong Y, Ou X, Jia J, You H. Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial. Am J Gastroenterol. 2024 Apr 1;119(4):700-711. doi: 10.14309/ajg.0000000000002569. Epub 2023 Nov 6.

  PMID: 37929952 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Xiaojuan Ou

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of liver research center

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: November 9, 2018
• Study Start: October 9, 2017
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-08

Locations

CN (6)