Endoscopic and Microbiological Assessment of the Effect of Carvedilol Combined With Berberine on GOV in Cirrhosis

NCT04543643 | Unknown Phase 3

• 1 other identifier: Tianjin2PH
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. A lot of studies have shown that the imbalance of flora and the progress of portal hypertension are mutually causal. Berberine can regulate the intestinal flora.In this study, we evaluated the effect of carvedilol and berberine on reducing portal vein pressure by observing the changes of endoscopy，endoscopic ultrasonography and intestinal flora.

Conditions

Cirrhosis Due to Hepatitis B; Cirrhosis Due to Hepatitis C; Gastroesophageal Varices

Keywords

gastroesophageal varices; cirrhosis; carvedilol; berberine; Endoscopic ultrasonography; gut microbiota; portal hypertension

Outcome Measures

Primary Outcomes (1)

• The progression Incidence of esophageal varices

  progression of esophagogastric varices under gastroscopy and/or endoscopic ultrasound

  1 year

Secondary Outcomes (2)

• The incidence of liver cirrhosis decompensation

  1 year

• HCC, death or liver transplantation

  1 year

Study Arms (2)

Carvedilol+ berberine

EXPERIMENTAL

Carvedilol is started at a dose of 6.25 mg once per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day if systolic blood pressure does not fall below 85mm Hg and HR 55/min. Berberine is started at a dose of 0.3g twice per day.

Drug: Carvedilol; Drug: Berberine

Carvedilol

ACTIVE COMPARATOR

Carvedilol is started at a dose of 6.25 mg once per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day if systolic blood pressure does not fall below 85 mm Hg and HR 55/min.

Drug: Carvedilol

Interventions

Carvedilol DRUG

As the third generation of NSBB, carvedilol is more effective in reducing HVPG than propranolol, which is recommended by Baveno VI as the first-line drug for EVB primary prevention.

Carvedilol; Carvedilol+ berberine

Berberine DRUG

Berberine can regulate the intestinal flora, which is safe and effective in clinical application.

Carvedilol+ berberine

Eligibility Criteria

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

You may qualify if:

• HBV-related or/and HCV-related liver cirrhotic patients based on pathology or clinical diagnosis;
• Antiviral therapy;
• Male or Female;
• ES showed the presence of esophageal and gastric varices and / or red signs;
• Child-Pugh \< 10, and meld \< 29;
• Signature of informed consent.

You may not qualify if:

• Used antibiotics, prebiotics, probiotics and proton pump inhibitors within 2 weeks;
• 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 / min), cardiogenic shock, hypotension (SBP \< 85mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease;
• Unstable high blood pressure and long-term engagement in driving;
• Any malignancy that affects survival, excluding the cured;
• Patients with portal thrombosis;
• PT extension greater than 4 seconds, PLT\<30×10\^9/L;
• Pregnant and lactating patients;
• 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;
• Patients with severe diseases of vital organs such as heart, lung, kidney, brain, blood and nervous system;
• Allergic to carvedilol and berberine;
• Severe systemic diseases；
• hemolytic anemia and lack of glucose - 6 - phosphate dehydrogenase patients
• Refusal to participate in the study.

Sponsors & Collaborators

• Tianjin Second People's Hospital: lead

Study Sites (1)

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, 300192, China

Location

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MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Interventions

Carvedilol; Berberine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System 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; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings

Central Study Contacts

Han Ping, bachelor

CONTACT

13652139315; 13652139315@163.com

Li Jia, professor

CONTACT

13302106853; 18622663700@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: November 1, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

CN (1)