[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582266":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":60,"collaborators":31,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":31,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","All patients will receive Carvedilol per os (dose escalation up to 12.5 mg per day).",[13],"Drug: Carvedilol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Carvedilol","Carvedilol per os, day 1:3.125 mg once, day 2 to day 8: 6.25 mg\u002Fday (3.125 mg twice a day), day 9 to day 90 (end of study visit): 12.5 mg\u002Fday (6.25 mg twice a day).\n\nAfter the end of the study, treatment with Carvedilol will be prescribed by a cardiologist and continued at the dose of 12.5 mg\u002Fday.\n\nThe follow-up of the patient will be then done according to the standard practice.",[9],[21],"CARVEDILOL ARROW ® 6,25 mg",[23],{"name":24,"affiliation":5,"role":25},"Armando Abergel","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Lise Laclautre","CONTACT","+33473754963",null,"promo_internet_drci@chu-clermontferrand.fr",[34,48],{"facility":28,"status":35,"city":36,"state":31,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"NOT_YET_RECRUITING","Clermont-Ferrand","63000","France","FR",{"type":41,"coordinates":42},"Point",[43,44],3.08682,45.77969,{"lat":44,"lon":43},[47],{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"facility":49,"status":50,"city":36,"state":31,"zip":51,"country":38,"countryCode":39,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Chu Estaing Medecine Digestive Et Hepatobiliaire","RECRUITING","63003",{"type":41,"coordinates":53},[43,44],{"lat":44,"lon":43},[56],{"name":57,"role":29,"phone":58,"phoneExt":31,"email":59},"Armando ABERGEL","+33473750523","aabergel@chu-clermontferrand.fr",{"type":61,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100582266","carpeus--effect-of-carvedilol-on-the-portosystemic-gradient-as-measured-by-endoscopic-ultrasound-100582266",false,"NCT06861075","CARPEUS : Effect of Carvedilol on the Portosystemic Gradient as Measured by Endoscopic Ultrasound","CARPEUS","Inclusion Criteria:\n\n* Patients ≥ 18 years\n* Suspected portal hypertension associated with cirrhosis (of any aetiology) as defined by:\n\n  1. Baveno VII criteria :\n\n     Liver stiffness ≥ 25 kPa Or Liver stiffness between 20 and 25 kPa and platelets \\\u003C 150 G\u002FL Or Liver stiffness between 15 and 20 kPa and platelets \\\u003C 110 G\u002FL Or Liver stiffness \\> 20 kPa and\u002For platelets \\\u003C 150 G\u002FL in patients with cirrhosis due to NASH\n\n     Or Oesophageal varices with high risk of bleeding :\n\n     Size \\> 5 mm (stage 2 or 3) Or Size ≤ 5 mm and red spots Or Size ≤ 5 mm and Child-Pugh score C\n  2. and\u002For the presence of a radiological sign of portal hypertension : Portosystemic shunts: rectal varices, splenorenal shunts, repermeabilization of the umbilical vein.\n  3. and\u002For splenic elasticity \\> 50 kPa.\n* Patients naive to treatment with cardioselective beta blockers\n* Affiliated to french health insurance system\n\nExclusion Criteria:\n\n* Absolute contraindications to beta blockers :\n\n  * hypersensitivity to the active substance (carvedilol) or to any of the excipients listed in section 6.1 of the summary of product characteristics\n  * patients with severe decompensated heart failure, with signs of fluid overload (oedema, ascites, pulmonary stasis rales), and\u002For requiring treatment with a positive inotrope or venous vasodilator\n  * second and third-degree atrioventricular blocks (unless presence of a permanent pacemaker)\n  * severe bradycardia (≤ 50 bpm)\n  * cardiac sinus disease (including sino-auricular block)\n  * severe hypotension (systolic pressure \\\u003C 85 mm Hg)\n  * cardiogenic shock\n  * severe asthma, severe chronic obstructive pulmonary disease, history of severe bronchospasm\n  * history of anaphylactic reaction\n  * Raynaud's phenomenon\n  * peripheral circulatory disorder: severe obliterative arterial disease of the lower limbs\n  * association with cimetidine\n  * association with class I antiarrhythmics except lidocaine\n  * pulmonary arterial hypertension\n* Presence of severe acute alcoholic hepatitis (Madrey score ≥ 32).\n* Current hepatic encephalopathy ≥ Grade 2.\n* Ongoing hepato-renal syndrome.\n* Profuse clinical ascites (only if it interferes with the feasibility of echo-endoscopy).\n* History of oesophageal varices rupture.\n* Hepatocellular carcinoma active or in remission for less than six months.\n* Active or resolved portal vein thrombosis for less than six months.\n* History of digestive surgery that does not allow the porto-systemic gradient to be measured using echo-endoscopy (gastrectomy, by-pass, etc.).\n* Patients taking antiaggregants (except acetylsalicylic acid) or anticoagulants for embologenic CA\u002FFA.\n* Severe stage 4 chronic renal insufficiency or stage 5 end-stage renal insufficiency (clearance \\\u003C 30 mL\u002Fmin).\n* Pregnant or breast-feeding women, or those planning to become pregnant\\*.\n\n  \\*A pregnancy test will be carried out for women of childbearing potential, and the investigator will ensure that effective contraception is in place while Carvedilol is being taken and for 5 half-lives after stopping it.\n* Patients protected by law (under guardianship, curatorship or safeguard of justice) or deprived of their freedom.\n* Patients currently taking part in another clinical research protocol.\n* Patients who do not understand French language.","ALL","18 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"NA","The purpose of this study is to assess the efficacy after one month of treatment with Carvedilol (12.5 mg daily) in primary prophylaxis of digestive haemorrhage due to portal hypertension in cirrhosis, by endoscopic ultrasound-guided portal pressure gradient measurement.",[79,80],"Cirrhosis","Portal Hypertension Related to Cirrhosis",[82,83,84],"Carvedilol.","Portal hypertension in cirrhosis.","EUS-PPG measurement.","2025-09-17",{"date":87,"type":88},"2025-09-22","ACTUAL",{"date":90,"type":88},"2025-04-16",{"date":92,"type":73},"2028-04-01",{"name":5,"class":6},2]