protocolSection identificationModule nctId: NCT06263816, orgStudyIdInfo id: CARVECIR, briefTitle: 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, acronym: CARVECIR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-11-15, primaryCompletionDateStruct date: 2029-10-15, completionDateStruct date: 2030-06-15, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Tours, class: OTHER, collaborators name: Centre Hospitalier Universitaire Amiens Picardie, collaborators name: Centre Hospitalier Universitaire Angers, collaborators name: Assistance Publique Hopitaux Paris BEAUJON, collaborators name: Centre Hospitalier Universitaire Caen, collaborators name: Centre Hospitalier intercommunal de Créteil, collaborators name: Hospices Civils de Lyon, collaborators name: Centre Hospitalier Universitaire Grenoble, collaborators name: Centre Hospitalier Universitaire Haut Lévêque, collaborators name: Centre Hospitalier Régional Universitaire Lille, collaborators name: Centre Hospitalier Universitaire Jean Minjoz, collaborators name: Assistance Publique Hopitaux Paris AVICENNE, collaborators name: Centre Hospitalier Universitaire Clermont Ferrand, collaborators name: Assistance Publique Hopitaux Paris LA PITIE SALPETRIERE, collaborators name: Centre Hospitalier Universitaire Pontchaillou, collaborators name: Assistance Publique Hopitaux Paris ST ANTOINE, collaborators name: Assistance Publique Hopitaux Paris PAUL BROUSSE, collaborators name: University Hospital, Montpellier, collaborators name: Assistance Publique Hopitaux Paris HENRI MONDOR, collaborators name: Centre Hospitaliser Départemental de Vendée, collaborators name: Nantes University Hospital, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: CHU de Reims, collaborators name: Hôpitaux Universitaires de Strasbourg, collaborators name: University Hospital, Toulouse, descriptionModule briefSummary: 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., conditionsModule conditions: Asymptomatic Cirrhosis, conditions: Clinically Significant Portal Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be a national multicentric, phase III, superiority double-blinded randomized controlled trial with two parallel arms: carvedilol versus placebo. The primary end-point will be assessed by the local investigator (hepatologist), blinded of the randomization arm, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Experimental group: Patients will be treated with carvedilol., interventions name: Control group: Patients will receive a placebo., outcomesModule primaryOutcomes measure: To evaluate the effect of low dose carvedilol (<=12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liver-related death at 36 months, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens Picardie, city: Amiens, country: France, contacts name: NGUYEN KHAC Eric, Dr, role: CONTACT, email: nguyen-khac.eric@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, locations facility: CHU Angers, city: Angers, country: France, contacts name: OBERTI FREDERIC, role: CONTACT, email: froberti@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Beaujon, city: Assistance Publique Hôpitaux De Paris, country: France, contacts name: RAUTOU PIERRE EMMANUEL, Dr, role: CONTACT, email: pierre-emmanuel.rautou@aphp.fr, locations facility: CHU Jean Minjoz, city: Besançon, country: France, contacts name: WEIL DELPHINE, Dr, role: CONTACT, email: dweil@chu-besancon.fr, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Haut Lévêque, city: Bordeaux, country: France, contacts name: DE LEDINGHEN VICTOR, Dr, role: CONTACT, email: victor.deledinghen@chu-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Caen, city: Caen, country: France, contacts name: OLLIVIER-HOURMAND Isabelle, Dr, role: CONTACT, email: ollivierhourmand-i@chu-Caen.fr, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CH intercommunal de Créteil, city: CH Intercommunal De Créteil, country: France, contacts name: ROSA ISABELLE, dR, role: CONTACT, email: isabelle.rosa@chi-creteil.fr, locations facility: CHU Clermont Ferrand, city: Clermont Ferrand, country: France, contacts name: ABERGEL ARMAND, Dr, role: CONTACT, email: aabergel@chu-clermontferrand.fr, geoPoint lat: 45.77966, lon: 3.08628, locations facility: Hôpital Henri Mondor, city: Créteil, country: France, contacts name: LEROY Vincent, Dr, role: CONTACT, email: vincent.leroy2@aphp.fr, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Hôpital Francois Mitterrand, city: Dijon, country: France, contacts name: MINELLO Anne, Dr, role: CONTACT, email: anne.minello@chu-dijon.fr, geoPoint lat: 47.31667, lon: 5.01667, locations facility: CHU Grenoble, city: Grenoble, country: France, contacts name: HILLERET Marie-Noelle, Dr, role: CONTACT, email: mnhilleret@chu-grenoble.fr, geoPoint lat: 45.16667, lon: 5.71667, locations facility: Centre Hospitalier départemental de Vendée, city: La Roche-sur-Yon, country: France, contacts name: LAGIN Ludovic, Dr, role: CONTACT, email: ludovic.lagin@ght85.fr, geoPoint lat: 46.66667, lon: -1.43333, locations facility: Hôpital Huriez, city: Lille, country: France, contacts name: LOUVET ALEXANDRE, Dr, role: CONTACT, email: alexandre.louvet@chru-lille.fr, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU la Croix Rousse, city: Lyon, country: France, contacts name: LEBOSSE FANNY, Dr, role: CONTACT, email: fanny.lebosse@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: CHU de Montpellier, city: Montpellier, country: France, contacts name: URSIC Jose, Dr, role: CONTACT, email: jose.ursicbedoya@chu-montpellier.fr, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Hôtel Dieu, city: Nantes, country: France, contacts name: ARCHAMBEAUD Isabelle, Dr, role: CONTACT, email: isabelle.archambeaud@chu-nantes.fr, geoPoint lat: 47.21725, lon: -1.55336, locations facility: CHU Avicenne, city: Paris, country: France, contacts name: BLAISE LORAINE, Dr, role: CONTACT, email: lorraine.blaise@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Pitié-Salpêtrière, city: Paris, country: France, contacts name: THABUT DOMINIQUE, Dr, role: CONTACT, email: dominique.thabut@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU Saint-Antoin, city: Paris, country: France, contacts name: OZENNE Violaine, Dr, role: CONTACT, email: violaine.ozenne@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Reims, city: Reims, country: France, contacts name: BERNARD CHABERT Brigitte, Dr, role: CONTACT, email: bbernard-chabert@chu-reims.fr, geoPoint lat: 49.25, lon: 4.03333, locations facility: CHU Pontchaillou, city: Rennes, country: France, contacts name: JEZEQUIEL Caroline, Dr, role: CONTACT, email: caroline.jezequiel@chu-rennes.fr, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Hôpitaux Universitaires de Strasbourg, city: Strasbourg, country: France, contacts name: TRIPON Simona, Dr, role: CONTACT, email: simona.tripon@chru-strasbourg.fr, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU de Toulouse, city: Toulouse, country: France, contacts name: BUREAU Christophe, Dr, role: CONTACT, email: bureau.c@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Hôpital Paul Brousse, city: Villejuif, country: France, contacts name: KOUNIS Ilias, Dr, role: CONTACT, email: ilias.kounis@aphp.fr, geoPoint lat: 48.7939, lon: 2.35992, hasResults: False