Carvedilol vs. Propranolol in Second Prophylaxis of Variceal Bleeding

NCT05651789 | Unknown

• 1 other identifier: NSBB-RVB
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial was conducted to evaluate the efficacy and safety of carvedilol versus propranolol, combined with routine endoscopic treatment, in the secondary prophylaxis of variceal bleeding in patients with cirrhosis.

Conditions

Portal Hypertension; Varice Bleed; Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• Variceal rebleeding rate

  Acute variceal rebleeding rate at 1 year

  1 year

Secondary Outcomes (3)

• Further decompensation rate

  1 year

• Adverse events

  1 year

• Transplant-free survival rate

  1 year

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 12.5mg/d. Doses are increased 3 days later. Avoid systolic blood pressure \<90 mmHg.

Drug: Carvedilol

Propranolol

ACTIVE COMPARATOR

Propranolol is started at a dose of 20 mg/d and the dose will be increased by 10 mg twice a day steps every 2-3 days until the target (heart rate: 55\~60 bpm) or to a maximum dose of 160 mg/d. Systolic arterial pressure is not less than 90 mm Hg and heart rate is not less than 50 bpm.

Drug: Propranolol

Interventions

Carvedilol DRUG

Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 12.5mg/d. Doses are increased 3 days later. Avoid systolic blood pressure \<90 mmHg.

Also known as: carvedilol as the nonselective beta-blockers

Carvedilol

Propranolol DRUG

Propranolol is started at a dose of 20 mg/d and the dose will be increased by 10 mg twice a day steps every 2-3 days until the target (heart rate: 55\~60 bpm) or to a maximum dose of 160 mg/d. Systolic arterial pressure is not less than 90 mm Hg and heart rate is not less than 50 bpm.

Also known as: propranolol as the nonselective beta-blockers

Propranolol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 80 years old;
• With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image;
• At least 5 days after index variceal bleeding;
• Informed consent.

You may not qualify if:

• Refusal to participate in the study;
• Portal hypertension resulting from other causes than liver cirrhosis;
• More than 42 days after index variceal bleeding;
• Bleeding from cardiofundal gastric varices;
• Portal venous thrombosis \>50% of the portal vein trunk;
• Contraindications to beta-blockers (asthma, chronic obstructive pulmonary disease, atrioventricular block, heart failure, bradycardia with HR ≤40 bpm, arteria hypotension with systolic blood pressure \<90 mm Hg, peripheral arterial disease, uncontrolled diabetes);
• Prior NSBB+EVL combined treatment, TIPS implantation or surgical shunt as secondary prophylaxis of variceal bledding;
• Chronic kidney disease;
• Pregnancy or lactation;
• Neoplastic disease.

Sponsors & Collaborators

• West China Hospital: lead
• Chengdu Shangjin Nanfu Hospital: collaborator
• West China Tianfu Hospital: collaborator

MeSH Terms

Conditions

Hypertension, Portal; Liver Cirrhosis

Interventions

Carvedilol; Propranolol

Condition Hierarchy (Ancestors)

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

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; Phenoxypropanolamines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Xuefeng Luo, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuefeng Luo, M.D.

CONTACT

+8613880098212; luo_xuefeng@wchscu.cn

Xiaoze Wang, M.D.

CONTACT

+8615208207573; wang_xiaoze@wchscu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hepatology

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 15, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share