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

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.

NCT Number	NCT06263816
Lead Sponsor	University Hospital, Tours Collaborators: Centre Hospitalier Universitaire Amiens Picardie, University Hospital, Angers, Assistance Publique Hopitaux Paris BEAUJON, Centre Hospitalier Universitaire de Caen, Centre Hospitalier intercommunal de Créteil, Hospices Civils de Lyon, Centre Hospitalier Universitaire Grenoble, Centre Hospitalier Universitaire Haut Lévêque, Centre Hospitalier Régional Universitaire Lille, Centre Hospitalier Universitaire Jean Minjoz, Assistance Publique Hopitaux Paris AVICENNE, Centre Hospitalier Universitaire Clermont Ferrand, Groupe Hospitalier Pitie-Salpetriere, Centre Hospitalier Universitaire Pontchaillou, Assistance Publique Hopitaux Paris ST ANTOINE, Assistance Publique Hopitaux Paris PAUL BROUSSE, University Hospital, Montpellier, Assistance Publique Hopitaux Paris HENRI MONDOR, Centre Hospitaliser Départemental de Vendée, Nantes University Hospital, Centre Hospitalier Universitaire Dijon, CHU de Reims, Hôpitaux Universitaires de Strasbourg, University Hospital, Toulouse
Conditions	Asymptomatic Cirrhosis, Clinically Significant Portal Hypertension
Enrollment	290 participants
Start Date	2025-06-17
Primary Completion	2027-07-17 (estimated)
Study Completion	2030-07-17 (estimated)
Updated on ClinicalTrials.gov	2025-06-04