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0SF",{"type":74,"coordinates":1200},[1201,1202],-4.25763,55.86515,{"lat":1202,"lon":1201},[1205],{"name":109,"role":61,"phone":110,"phoneExt":25,"email":63},{"type":1207,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[1209,1212],{"name":1210,"class":1211},"Saint Luke's Mid America Heart Institute","UNKNOWN",{"name":1213,"class":1214},"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":1226,"type":1227},1500,"ESTIMATED","INTERVENTIONAL",[1230],"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.",[1233],"Heart Failure",[1233,1235],"Hospitalized","2026-07-22",{"date":1238,"type":1239},"2026-07-23","ACTUAL",{"date":1241,"type":1239},"2024-07-09",{"date":1243,"type":1227},"2027-11",{"name":5,"class":6},104]