[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517992":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":25,"armGroups":37,"interventions":48,"overallOfficials":25,"centralContacts":58,"locations":64,"responsibleParty":216,"collaborators":218,"id":225,"slug":25,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":226,"sex":232,"minAge":233,"maxAge":25,"enrollmentInfo":234,"targetDuration":25,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Colorado Prevention Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":25},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Clinical benefit","Hierarchical composite of the following:\n\n* Time to all-cause mortality\n* Number of total HF events\n* Time to first HF event\n* Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method","6 months",{"measure":14,"description":15,"timeFrame":12},"Number of serious adverse events (AEs).","\\- Serious AEs (excluding efficacy endpoints).",{"measure":17,"description":18,"timeFrame":12},"Number of adverse events leading to discontinuation of study drug.","\\- AEs leading to discontinuation of finerenone or empagliflozin.",[20,23,26],{"measure":21,"description":22,"timeFrame":12},"Time to first death from any cause or HF event.","Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)",{"measure":24,"description":25,"timeFrame":12},"Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).",null,{"measure":27,"description":28,"timeFrame":29},"Number of HF events from baseline to Day 90.","\\- Total (first and recurrent) HF events.","90 days",{"allocation":31,"interventionModel":32,"interventionModelDescription":25,"primaryPurpose":33,"observationalModel":25,"timePerspective":25,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":25,"whoMasked":25},"NONE","This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).",[38,44],{"label":39,"type":40,"description":25,"interventionNames":41},"Finerenone plus empagliflozin","EXPERIMENTAL",[42,43],"Drug: Finerenone","Drug: Empagliflozin",{"label":45,"type":46,"description":47,"interventionNames":25},"Usual care","NO_INTERVENTION","Usual care management",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":25},"DRUG","Finerenone","Oral finerenone.",[39],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":25},"Empagliflozin","Oral empagliflozin.",[39],[59],{"name":60,"role":61,"phone":62,"phoneExt":25,"email":63},"Marc Bonaca","CONTACT","(303) 860-9900","info@cpcmed.org",[65,79,89,98,108,118,130,140,149,161,171,181,189,201,206],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":25},"CON-10004 Fairhope, AL Investigational Site","RECRUITING","Fairhope","Alabama","36532","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-87.90333,30.52297,{"lat":77,"lon":76},{"facility":80,"status":67,"city":81,"state":82,"zip":83,"country":71,"countryCode":72,"cosmosGeoPoint":84,"geoPoint":88,"contacts":25},"CON-10075 El Centro, CA Investigational Site","El Centro","California","92243",{"type":74,"coordinates":85},[86,87],-115.56305,32.792,{"lat":87,"lon":86},{"facility":90,"status":67,"city":91,"state":82,"zip":92,"country":71,"countryCode":72,"cosmosGeoPoint":93,"geoPoint":97,"contacts":25},"CON-10024 Sacramento, CA Investigational Site","Sacramento","95816",{"type":74,"coordinates":94},[95,96],-121.4944,38.58157,{"lat":96,"lon":95},{"facility":99,"status":67,"city":100,"state":101,"zip":102,"country":71,"countryCode":72,"cosmosGeoPoint":103,"geoPoint":107,"contacts":25},"CON-10022 Atlanta, GA Investigational Site","Atlanta","Georgia","30303",{"type":74,"coordinates":104},[105,106],-84.38798,33.749,{"lat":106,"lon":105},{"facility":109,"status":67,"city":110,"state":111,"zip":112,"country":71,"countryCode":72,"cosmosGeoPoint":113,"geoPoint":117,"contacts":25},"CON-10030 Baton Rouge, LA Investigational Site","Baton Rouge","Louisiana","70808",{"type":74,"coordinates":114},[115,116],-91.18747,30.44332,{"lat":116,"lon":115},{"facility":119,"status":67,"city":120,"state":121,"zip":122,"country":71,"countryCode":72,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"CON-10002 Kansas City, MO Investigative Site","Kansas City","Missouri","64111",{"type":74,"coordinates":124},[125,126],-94.57857,39.09973,{"lat":126,"lon":125},[129],{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":131,"status":67,"city":132,"state":133,"zip":134,"country":71,"countryCode":72,"cosmosGeoPoint":135,"geoPoint":139,"contacts":25},"CON-10045 Amarillo, TX Investigational Site","Amarillo","Texas","79106",{"type":74,"coordinates":136},[137,138],-101.8313,35.222,{"lat":138,"lon":137},{"facility":141,"status":67,"city":142,"state":133,"zip":143,"country":71,"countryCode":72,"cosmosGeoPoint":144,"geoPoint":148,"contacts":25},"CON-10015 Austin, TX Investigational Site","Austin","78705",{"type":74,"coordinates":145},[146,147],-97.74306,30.26715,{"lat":147,"lon":146},{"facility":150,"status":67,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":25},"CON-21003 Goiania, Goias Investigational Site","Goiânia","Goiás","74453-200","Brazil","BR",{"type":74,"coordinates":157},[158,159],-49.25389,-16.67861,{"lat":159,"lon":158},{"facility":162,"status":67,"city":163,"state":164,"zip":165,"country":154,"countryCode":155,"cosmosGeoPoint":166,"geoPoint":170,"contacts":25},"CON-21007 Joinville, Santa Catarina Investigational Site","Joinville","Santa Catarina","89200-000",{"type":74,"coordinates":167},[168,169],-48.84556,-26.30444,{"lat":169,"lon":168},{"facility":172,"status":67,"city":173,"state":174,"zip":175,"country":154,"countryCode":155,"cosmosGeoPoint":176,"geoPoint":180,"contacts":25},"CON-21004 Braganca Paulista, Sao Paulo Investigational Site","Bragança Paulista","São Paulo","12916542",{"type":74,"coordinates":177},[178,179],-46.54418,-22.9527,{"lat":179,"lon":178},{"facility":182,"status":67,"city":174,"state":174,"zip":183,"country":154,"countryCode":155,"cosmosGeoPoint":184,"geoPoint":188,"contacts":25},"CON-21049 Sao Paulo, Sao Paulo Investigational Site","05652-900",{"type":74,"coordinates":185},[186,187],-46.63611,-23.5475,{"lat":187,"lon":186},{"facility":190,"status":67,"city":191,"state":192,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":25},"CON-11012 Surry, BC Investigational Site","Surrey","British Columbia","V3V OC6","Canada","CA",{"type":74,"coordinates":197},[198,199],-122.82509,49.10635,{"lat":199,"lon":198},{"facility":202,"status":67,"city":203,"state":204,"zip":205,"country":194,"countryCode":195,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"CON-11007 North York, ON Investigational Site","North York","Ontario","M6B 3H7",{"facility":207,"status":67,"city":208,"state":209,"zip":210,"country":194,"countryCode":195,"cosmosGeoPoint":211,"geoPoint":215,"contacts":25},"CON-11005 Sherbrooke, QC Investigational Site","Sherbrooke","Quebec","J1H 5N4",{"type":74,"coordinates":212},[213,214],-71.89908,45.40008,{"lat":214,"lon":213},{"type":217,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[219,222],{"name":220,"class":221},"Saint Luke's Mid America Heart Institute","UNKNOWN",{"name":223,"class":224},"Bayer Healthcare Pharmaceuticals, Inc.\u002FBayer Schering Pharma","INDUSTRY","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":235,"type":236},1500,"ESTIMATED","INTERVENTIONAL",[239],"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.",[242],"Heart Failure",[242,244],"Hospitalized","2025-03-06",{"date":247,"type":248},"2025-03-11","ACTUAL",{"date":250,"type":248},"2024-07-09",{"date":252,"type":236},"2026-08",{"name":5,"class":6},15]