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 Control Trial

Summary

Decompensation of cirrhosis is a turning point in cirrhosis course, as associated with a marked decrease in life expectancy. Thus, prevention of decompensation is crucial.

The usefulness of carvedilol to prevent decompensation of cirrhosis in patients with TE-LSM ≥ 25 kPa as a surrogate marker for clinically significant portal hypertension, has never been evaluated in a clinical trial.

Conditions

• Asymptomatic Cirrhosis
• Clinically Significant Portal Hypertension

Interventions

DRUG

Experimental group: Patients will be treated with carvedilol.

Patients will receive the number of pills of carvedilol corresponding to the dose determined during the titration period (either one pill of 6.25 mg in the morning or 1 pill of 6.25 mg twice a day, 1 in the morning and 1 in the evening.

OTHER

Control group: Patients will receive a placebo.

Patients will receive the number of pills of placebo corresponding to the dose determined during the titration period (either one pill in the morning or 1 pill twice a day: 1 in the morning and 1 in the evening).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Amiens Picardie

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Angers

  collaborator UNKNOWN

• Assistance Publique Hopitaux Paris BEAUJON

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Caen

  collaborator UNKNOWN

• Centre Hospitalier intercommunal de Créteil

  collaborator UNKNOWN

• Hospices Civils de Lyon

  collaborator OTHER

• Centre Hospitalier Universitaire Grenoble

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Haut Lévêque

  collaborator UNKNOWN

• Centre Hospitalier Régional Universitaire Lille

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Jean Minjoz

  collaborator UNKNOWN

• Assistance Publique Hopitaux Paris AVICENNE

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Clermont Ferrand

  collaborator UNKNOWN

• Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Pontchaillou

  collaborator UNKNOWN

• Assistance Publique Hopitaux Paris ST ANTOINE

  collaborator UNKNOWN

• Assistance Publique Hopitaux Paris PAUL BROUSSE

  collaborator UNKNOWN

• University Hospital, Montpellier

  collaborator OTHER

• Assistance Publique Hopitaux Paris HENRI MONDOR

  collaborator UNKNOWN

• Centre Hospitaliser Départemental de Vendée

  collaborator UNKNOWN

• Nantes University Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• CHU de Reims

  collaborator OTHER

• Hôpitaux Universitaires de Strasbourg

  collaborator UNKNOWN

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Principal Investigators

• Laure ELKRIEF, MD-PhD · University Hospital, Tours

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-17

Primary Completion

2027-07-17

Completion

2030-07-17

Countries

• France

Study Locations