[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568902":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":40,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":11,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"METFORMIN GROUP","EXPERIMENTAL",null,[13],"Drug: Metformin",{"label":15,"type":16,"description":11,"interventionNames":17},"PLACEBO GROUP","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Metformin","one pill of 500 mg per os twice a day for 28 days.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo","one pill per os twice a day for 28 days.",[15],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"LUCILE MOGA","CONTACT","01 71 11 46 69","+33","lucile.moga@aphp.fr",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"PIERRE EMMANUEL RAUTOU","01 40 87 52 83","pierre-emmanuel.rautou@aphp.fr",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Facility Name: Beaujon hospital","RECRUITING","Clichy","France","92110","FR",{"type":49,"coordinates":50},"Point",[51,52],2.30952,48.90018,{"lat":52,"lon":51},[55,58,60],{"name":56,"role":32,"phone":57,"phoneExt":11,"email":35},"Lucile MOGA, Dre","00331-71-11-46-69",{"name":59,"role":32,"phone":57,"phoneExt":11,"email":39},"Pierre Emmanuel Rautou, Pr",{"name":56,"role":61,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100568902","phase-2-effects-of-metformin-on-hepatic-venous-pressure-gradient-in-patients-with-cirrhosis-and-portal-hypertension-100568902",false,"NCT06687265","Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension","Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension - A Randomized Placebo-controlled Study","Hyper-Met","Inclusion Criteria:\n\n* \\- Age ≥ 18 years\n* Written informed consent to participate in the study\n* Medical insurance coverage\n* For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception\n* Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence\n* Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside\u002Fnucleotide analog treatment for HBV) for at least 6 months\n* Child-Pugh A or B\n* High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria:\n\n  1. Investigator's judgement\n  2. active cause of cirrhosis and:\n\n     * History of clinical ascites\n     * Or history of variceal bleeding\n     * Or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last two years\n     * or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last two years\n     * or liver surface nodularity ≥ 2,9 in the last two years\n     * or HVPG \\> 16 mm Hg prior to starting NSBB\n     * or Laennec 4c cirrhosis on histology\n  3. or resolution of the cause of cirrhosis for at least 6 months and:\n\n     * history of clinical ascites in the last 6 months\n     * or history of variceal bleeding in the last 6 months\n     * or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last 6 months\n     * or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last 6 months\n     * or liver surface nodularity ≥ 2,9 in the last 12 months\n     * or Laennec 4c cirrhosis on histology in the last 12 months\n* Treatment with carvedilol (≥ 6,25 mg\u002Fday) at a stable dose for at least one month\n* Absence of hepatocellular carcinoma outside at least one nodule \\> 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months\n\nExclusion Criteria:\n\n* Serum total bilirubin \\> 50 µmol\u002FL\n* Prothrombin ratio \\\u003C 50 %\n* Transaminases \\> 5 ULN\n* Need for at least one paracentesis for ascites fluid evacuation in the last 6 months\n* Expected follow-up \\\u003C 3 months\n* Known hypersensitivity to the active substance or any of the excipients\n* History of lactic acidosis, diabetic acidocetosis, or diabetic precoma\n* Ongoing condition that may lead to acute kidney injury or hypoxia: dehydration, severe infection, shock, cardiac decompensation, respiratory failure, or myocardial infarction within the past month\n* Known hypersensitivity to all the iodin-containing contrast agents\n* Known hypersensitivity to lidocaine for local anesthesia\n* Known hypersensitivity to beta-lactam antibiotics if the patient has a history of valve replacement\n* Alcohol consumption \\> 14 units\u002Fweek for women or \\> 21 units\u002Fweek for men, current or abstinent for less than 6 months\n* Biliary cirrhosis\n* Hepatocellular carcinoma with at least one nodule \\> 3 cm in diameter, or more than 3 nodules\n* Cholangiocarcinoma\n* Extra-hepatic cancer without remission\n* Severe chronic kidney disease defined as estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1,73m2 using the MDRD-6 formula\n* Ongoing treatment with metformin, or discontinued for less than 3 months\n* Treatment with statins started or discontinued for less than 3 months\n* Treatment with nucleoside\u002Fnucleotide analogue for HBV, or direct-acting antiviral treatment for HCV, started for less than 6 months\n* Complete portal vein thrombosis (main portal trunk, or right branch), or portal cavernoma\n* History of TIPS (transjugular intrahepatic portosystemic shunt) \u002F surgical portosystemic derivation \u002F liver transplantation \u002F major hepatectomy\n* Ongoing participation in another interventional therapeutic trial\n* Pregnant or breastfeeding women\n* Patients unable to give consent (under guardianship or curatorship)\n* Non-randomisation criteria: HVPG \\\u003C 12 mm Hg at the catheterism performed during the first follow-up visit","ALL","18 Years",{"count":75,"type":76},76,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis.\n\nWhen the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a \" clinically significant PHT \": ascites and oesophageal varices (EV) may occur.\n\nAbove 12 mm Hg, there is a risk of variceal bleeding. Carvedilol, a non-selective beta-blocker (NSBB), is recommended in all the patients with cirrhosis and clinically significant PHT in order to prevent decompensation of cirrhosis.\n\nNevertheless, 40 % of patients are NSBB non-responders, i.e. they do not show a significant decrease in HVPG. In addition, NSBB responders treated for primary prophylaxis have an incidence of variceal bleeding of approximately 10% per year, with a six-week mortality of 20%. Therefore, there is an unmet need for PHT in patients with cirrhosis who do not respond to NSBB, and also for an increase in efficacy in responders. In a randomised pilot study, Rittig et al. observed a mean change in HVPG of -2,9 mm Hg in 16 patients with cirrhosis and HVPG ≥ 12 mm Hg, not treated with NSBB, 90 minutes after ingestion of 1000 mg metformin.\n\nThe study will be a prospective, national, multicentre, phase II, superiority comparative randomized (1:1) simple-blinded clinical trial with two parallel arms: metformin versus placebo.\n\nThe main objective is to evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol.\n\nSubjects randomized in the metformin group or placebo group will receive metformin ou placebo, one pill of 500 mg per os twice a day (one in the morning and one in the evening, during or at the end of the meal) for 28 days.",[82,83],"Cirrhosis","Portal Hypertension Related to Cirrhosis",[85,86,87,88,89],"cirrhosis","portal hypertension","metformin","hepatic venous pressure gradient","carvedilol","2025-04-09",{"date":92,"type":93},"2025-04-13","ACTUAL",{"date":95,"type":93},"2025-03-10",{"date":97,"type":76},"2027-07-31",{"name":5,"class":6},1]