[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517992":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":187,"collaborators":189,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":198,"sex":204,"minAge":205,"maxAge":11,"enrollmentInfo":206,"targetDuration":11,"studyType":209,"phases":210,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Colorado Prevention Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Finerenone plus empagliflozin","EXPERIMENTAL",null,[13,14],"Drug: Finerenone","Drug: 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States","US",{"type":45,"coordinates":46},"Point",[47,48],-87.90333,30.52297,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"CON-10075 El Centro, CA Investigational Site","El Centro","California","92243",{"type":45,"coordinates":56},[57,58],-115.56305,32.792,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":53,"zip":63,"country":42,"countryCode":43,"cosmosGeoPoint":64,"geoPoint":68,"contacts":11},"CON-10024 Sacramento, CA Investigational Site","Sacramento","95816",{"type":45,"coordinates":65},[66,67],-121.4944,38.58157,{"lat":67,"lon":66},{"facility":70,"status":38,"city":71,"state":72,"zip":73,"country":42,"countryCode":43,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"CON-10022 Atlanta, GA Investigational Site","Atlanta","Georgia","30303",{"type":45,"coordinates":75},[76,77],-84.38798,33.749,{"lat":77,"lon":76},{"facility":80,"status":38,"city":81,"state":82,"zip":83,"country":42,"countryCode":43,"cosmosGeoPoint":84,"geoPoint":88,"contacts":11},"CON-10030 Baton Rouge, LA Investigational Site","Baton Rouge","Louisiana","70808",{"type":45,"coordinates":85},[86,87],-91.18747,30.44332,{"lat":87,"lon":86},{"facility":90,"status":38,"city":91,"state":92,"zip":93,"country":42,"countryCode":43,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"CON-10002 Kansas City, MO Investigative Site","Kansas City","Missouri","64111",{"type":45,"coordinates":95},[96,97],-94.57857,39.09973,{"lat":97,"lon":96},[100],{"name":31,"role":32,"phone":11,"phoneExt":11,"email":11},{"facility":102,"status":38,"city":103,"state":104,"zip":105,"country":42,"countryCode":43,"cosmosGeoPoint":106,"geoPoint":110,"contacts":11},"CON-10045 Amarillo, TX Investigational Site","Amarillo","Texas","79106",{"type":45,"coordinates":107},[108,109],-101.8313,35.222,{"lat":109,"lon":108},{"facility":112,"status":38,"city":113,"state":104,"zip":114,"country":42,"countryCode":43,"cosmosGeoPoint":115,"geoPoint":119,"contacts":11},"CON-10015 Austin, TX Investigational Site","Austin","78705",{"type":45,"coordinates":116},[117,118],-97.74306,30.26715,{"lat":118,"lon":117},{"facility":121,"status":38,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":11},"CON-21003 Goiania, Goias Investigational Site","Goiânia","Goiás","74453-200","Brazil","BR",{"type":45,"coordinates":128},[129,130],-49.25389,-16.67861,{"lat":130,"lon":129},{"facility":133,"status":38,"city":134,"state":135,"zip":136,"country":125,"countryCode":126,"cosmosGeoPoint":137,"geoPoint":141,"contacts":11},"CON-21007 Joinville, Santa Catarina Investigational Site","Joinville","Santa Catarina","89200-000",{"type":45,"coordinates":138},[139,140],-48.84556,-26.30444,{"lat":140,"lon":139},{"facility":143,"status":38,"city":144,"state":145,"zip":146,"country":125,"countryCode":126,"cosmosGeoPoint":147,"geoPoint":151,"contacts":11},"CON-21004 Braganca Paulista, Sao Paulo Investigational Site","Bragança Paulista","São Paulo","12916542",{"type":45,"coordinates":148},[149,150],-46.54418,-22.9527,{"lat":150,"lon":149},{"facility":153,"status":38,"city":145,"state":145,"zip":154,"country":125,"countryCode":126,"cosmosGeoPoint":155,"geoPoint":159,"contacts":11},"CON-21049 Sao Paulo, Sao Paulo Investigational Site","05652-900",{"type":45,"coordinates":156},[157,158],-46.63611,-23.5475,{"lat":158,"lon":157},{"facility":161,"status":38,"city":162,"state":163,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":11},"CON-11012 Surry, BC Investigational Site","Surrey","British Columbia","V3V OC6","Canada","CA",{"type":45,"coordinates":168},[169,170],-122.82509,49.10635,{"lat":170,"lon":169},{"facility":173,"status":38,"city":174,"state":175,"zip":176,"country":165,"countryCode":166,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"CON-11007 North York, ON Investigational Site","North York","Ontario","M6B 3H7",{"facility":178,"status":38,"city":179,"state":180,"zip":181,"country":165,"countryCode":166,"cosmosGeoPoint":182,"geoPoint":186,"contacts":11},"CON-11005 Sherbrooke, QC Investigational Site","Sherbrooke","Quebec","J1H 5N4",{"type":45,"coordinates":183},[184,185],-71.89908,45.40008,{"lat":185,"lon":184},{"type":188,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[190,193],{"name":191,"class":192},"Saint Luke's Mid America Heart Institute","UNKNOWN",{"name":194,"class":195},"Bayer Healthcare Pharmaceuticals, Inc.\u002FBayer Schering Pharma","INDUSTRY","100517992","phase-3-a-study-to-determine-the-efficacy-and-safety-of-finerenone-and-sglt2i-in-combination-in-hospitalized-patients-with-heart-failure-confirmation-hf-100517992",false,"NCT06024746","A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)","Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)","CONFIRMATION","Inclusion Criteria:\n\n* Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations\n* Age ≥18 years or legal age of majority if \\>18 years in the participant's country of residence\n* Current hospitalization or recently discharged with the primary diagnosis of heart failure\n* Heart failure signs and symptoms at the time of hospital admission\n* Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg\u002FmL or B-type natriuretic peptide (BNP) ≥125 pg\u002FmL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg\u002FmL or BNP ≥375 pg\u002FmL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission\n* Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)\n* Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).\n* Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis\n* Documented prior history of severe hyperkalemia in the setting of MRA use\n* Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m² and\u002For potassium \\>5.0 mmol\u002FL\n* Acute myocardial infarction, coronary revascularization, valve replacement\u002Frepair, or implantation of a cardiac resynchronization therapy device within 30 days\n* Prior or planned heart transplant\n* Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure\n* Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction\n* Probable alternative cause of participant's heart failure symptoms\n* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers\n* Known hypersensitivity to the IP (active substance or excipients)\n* Any other condition or therapy which would make the patient unsuitable for this study","ALL","18 Years",{"count":207,"type":208},1500,"ESTIMATED","INTERVENTIONAL",[211],"PHASE3","Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.",[214],"Heart Failure",[214,216],"Hospitalized","2025-03-06",{"date":219,"type":220},"2025-03-11","ACTUAL",{"date":222,"type":220},"2024-07-09",{"date":224,"type":208},"2026-08",{"name":5,"class":6},15]