[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550070":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":60,"responsibleParty":65,"collaborators":60,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":60,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":96,"whyStopped":60,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":60},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Dapa-Tonic","EXPERIMENTAL","This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily, severe water restriction (\\\u003C 500 mL), and SGLT2 inhibitors (Dapagliflozin).",[13,14],"Drug: Dapagliflozin tablet","Drug: Hypertonic Saline Solution, 1 Ml",{"label":16,"type":17,"description":18,"interventionNames":19},"Tonic-Placebo","PLACEBO_COMPARATOR","This group will undergo a 15-minute intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily along with severe water restriction (\\\u003C 500 mL).",[14],{"label":21,"type":17,"description":22,"interventionNames":23},"Furosemide-Placebo","This group will undergo intravenous furosemide twice daily and severe water restriction (\\\u003C 500 mL) without hypertonic saline solutions.",[24],"Drug: Furosemide Injection",{"label":26,"type":27,"description":28,"interventionNames":29},"Dapa-Furo","ACTIVE_COMPARATOR","This group will undergo intravenous furosemide without hypertonic saline solutions twice daily, severe water restriction (\\\u003C 500 mL), and SGLT2 inhibitors (Dapagliflozin).",[13,24],[31,38,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Dapagliflozin tablet","Dapagliflozin 10 mg 1 tablet once daily",[26,9],[37],"SGLT2 inhibitor",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Hypertonic Saline Solution, 1 Ml","Intravenous infusion of furosemide combined with hypertonic saline solutions (100 mL) twice daily",[9,16],[43],"Hypertonic Solution, Saline",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Furosemide Injection","Furosemide 20 mg",[26,21],[49],"FUROSEMIDE",[51],{"name":52,"affiliation":53,"role":54},"Giuseppe Miceli, PhD","A.O.U.P. Paolo Giaccone Palermo","PRINCIPAL_INVESTIGATOR",[56,62],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Antonino Tuttolomondo, Professor","CONTACT","+39 091 6552115",null,"bruno.tuttolomondo@unipa.it",{"name":52,"role":58,"phone":63,"phoneExt":60,"email":64},"+39 0916552197","miceli.gpp@gmail.com",{"type":54,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Antonino Tuttolomondo","Professor","100550070","phase-4-sglt-2-inhibitor-and-high-dose-furosemide-plus-small-volume-hypertonic-saline-solution-in-acute-hf-100550070",false,"NCT06442280","SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution in Acute HF","Enhanced Diuresis and Natriuresis in Acute Decompensated Heart Failure Patients Treated With SGLT-2 Inhibitor and High-Dose Furosemide Plus Small-Volume Hypertonic Saline Solution: A Clinical Trial","DAPA-TONIC","Inclusion Criteria:\n\n* acute heart failure;\n* diabetes type 2.\n\nExclusion Criteria:\n\n* low estimated glomerular filtration rate;\n* hypernatremia;\n* diabetes type 1;\n* non-cardiac causes of dyspnea;\n* cardiogenic shock;\n* recent occurrence of Acute Coronary Syndrome;\n* ketoacidosis;\n* hyperosmolar hyperglycemic syndrome.","ALL","40 Years","89 Years",{"count":80,"type":81},544,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","The purpose of the current investigation is to demonstrate the efficacy of high-dose furosemide plus small-volume hypertonic saline solution and a Sodium-Glucose cotransporter-2 (SGLT-2) inhibitor among patients admitted for acute exacerbation of heart failure, in determining a significant increase in diuresis and natriuresis. It is also accompanied by a rapid reduction in body weight and a substantial decrease in hospitalization length without compromising renal function.",[87,88,89,90],"Heart Failure Acute","Diabetes Type 2","Heart Failure With Reduced Ejection Fraction","Heart Failure With Preserved Ejection Fraction",[92,88,93,94,95],"Acute Heart Failure","SGLT-2 inhibitors","Furosemide","Hypertonic Solution","NOT_YET_RECRUITING","2024-06-04",{"date":99,"type":100},"2024-06-06","ACTUAL",{"date":102,"type":81},"2024-06",{"date":104,"type":81},"2026-03-30",{"name":5,"class":6}]