Carvedilol for Prevention of Esophageal Varices Progression

NCT ID: NCT03736265

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2022-12-30

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.

Conditions

Cirrhosis, Liver; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Carvedilol+ Nucleos(t)ide Analogues

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.

Group Type: EXPERIMENTAL

Carvedilol

Intervention Type: 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.

Nucleos(t)ide Analogues

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Carvedilol

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.

Intervention Type: DRUG

Other Intervention Names

Nucleos(t)ide Analogues

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaojuan Ou

Director of liver research center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojuan Ou

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37929952 (View on PubMed)

Other Identifiers

2017ZX10203202003

Identifier Type: -

Identifier Source: org_study_id