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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
Sponsor: University Hospital, Tours
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2025-06-17
Completion Date
2030-07-17
Last Updated
2025-06-04
Healthy Volunteers
No
Interventions
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.
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).
Locations (24)
CHU Amiens Picardie
Amiens, France
CHU Angers
Angers, France
CHU Beaujon
Assistance Publique Hôpitaux de Paris, France
CHU Jean Minjoz
Besançon, France
CHU Haut Lévêque
Bordeaux, France
CHU Caen
Caen, France
CH intercommunal de Créteil
CH Intercommunal de Créteil, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Hôpital Henri Mondor
Créteil, France
Hôpital Francois Mitterrand
Dijon, France
CHU Grenoble
Grenoble, France
Centre Hospitalier départemental de Vendée
La Roche-sur-Yon, France
Hôpital Huriez
Lille, France
CHU la Croix Rousse
Lyon, France
CHU de Montpellier
Montpellier, France
CHU Hôtel Dieu
Nantes, France
CHU Avicenne
Paris, France
CHU Pitié-Salpêtrière
Paris, France
CHU Saint-Antoin
Paris, France
CHU de Reims
Reims, France
CHU Pontchaillou
Rennes, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
CHU de Toulouse
Toulouse, France
Hôpital Paul Brousse
Villejuif, France