Effect of long-term carvedilol to prevent decompensation or death in patients with asymptomatic Child-Pugh A5 to B8 cirrhosis and clinically significant portal hypertension: a multicenter, double-blind, randomized controlled trial.

Conditions

Asymptomatic Child-Pugh A5 to B8 cirrhosis

Brief summary

Primary endpoint will be the occurrence, within 36 months after inclusion, of either decompensation of cirrhosis or liver-related death.

Detailed description

1. Safety of carvedilol (<=12.5 mg per day) on: (a) Systemic hemodynamics (heart rate, blood pressure), (b) Cardiac function (c) any other adverse effects and reactions within 36 months after inclusion, Effect of low dose carvedilol (<=12.5 mg per day), within 36 months after randomization, 3. To assess treatment compliance: record of unused packaging and information about compliance in a patient notebook, 4. To identify potential predictors of decompensation in the control group: - Levels of liver and spleen stiffness at baseline and at month 12 - Liver surface nodularity at baseline, 5. To identify potential predictors of response to carvedilol (in the group receiving carvedilol): - Levels and variation of liver and spleen stiffness at baseline, and week 2 - Heart rate, systolic and mean blood pressure and its variation at baseline and week 2, 6. Occurrence, within 36 months after inclusion, of either decompensation of cirrhosis or liver-related death according to subgroups (a) main etiology of cirrhosis (alcohol, viral, or metabolic) (b) history of previous decompensation (c) alcohol consumption (d) features of metabolic syndrome

Related papers

No related papers found yet.

Interventions

DRUGCarvedilol NORMON 6.25 mg tablets EFG.

DRUGIl n'a pas de substance active. Le produit est un comprimé pelliculé sécable blanc

DRUGde forme ovale

DRUGde longueur 8mm

DRUGavec une gravure F57 sur une face et une barre de sécabilité sur l’autre face. Excipients: Prosolv Easytab SP (Cellulose microcristalline

DRUGSilice colloïdale

DRUGSodium starch glycolate

DRUGSodium stéaryl fumarate). Solution de pelliculage: (Hypromellose

DRUGPEG 3350

DRUGCandurin silver sheen)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary endpoint will be the occurrence, within 36 months after inclusion, of either decompensation of cirrhosis or liver-related death.	—

Secondary

Measure	Time frame
1. Safety of carvedilol (<=12.5 mg per day) on: (a) Systemic hemodynamics (heart rate, blood pressure), (b) Cardiac function (c) any other adverse effects and reactions within 36 months after inclusion, Effect of low dose carvedilol (<=12.5 mg per day), within 36 months after randomization, 3. To assess treatment compliance: record of unused packaging and information about compliance in a patient notebook, 4. To identify potential predictors of decompensation in the control group: - Levels of liver and spleen stiffness at baseline and at month 12 - Liver surface nodularity at baseline, 5. To identify potential predictors of response to carvedilol (in the group receiving carvedilol): - Levels and variation of liver and spleen stiffness at baseline, and week 2 - Heart rate, systolic and mean blood pressure and its variation at baseline and week 2, 6. Occurrence, within 36 months after inclusion, of either decompensation of cirrhosis or liver-related death according to subgroups (a) main	—

Measure

Time frame

1. Safety of carvedilol (<=12.5 mg per day) on: (a) Systemic hemodynamics (heart rate, blood pressure), (b) Cardiac function (c) any other adverse effects and reactions within 36 months after inclusion, Effect of low dose carvedilol (<=12.5 mg per day), within 36 months after randomization, 3. To assess treatment compliance: record of unused packaging and information about compliance in a patient notebook, 4. To identify potential predictors of decompensation in the control group: - Levels of liver and spleen stiffness at baseline and at month 12 - Liver surface nodularity at baseline, 5. To identify potential predictors of response to carvedilol (in the group receiving carvedilol): - Levels and variation of liver and spleen stiffness at baseline, and week 2 - Heart rate, systolic and mean blood pressure and its variation at baseline and week 2, 6. Occurrence, within 36 months after inclusion, of either decompensation of cirrhosis or liver-related death according to subgroups (a) main

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Countries

France

Outcome results

None listed