[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594350":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":37,"responsibleParty":60,"collaborators":18,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":18,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Discharge with Subcutaneous Furosemide","EXPERIMENTAL","The practice group randomized to early discharge with subcutaneous furosemide home infusion will begin initiation of subcutaneous furosemide (LASIX-ONYU) with a SQIN-Infusor device prior to discharge from the hospital. Dosing will be based on pre-admission oral furosemide requirements. Those with a home dose of ≤80mg\u002Fday oral furosemide will receive 80mg subcutaneous once daily at home and those with \\>80mg\u002Fday oral furosemide will receive 80mg subcutaneous twice daily at home.",[13],"Combination Product: Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Usual inpatient care with IV furosemide. Discharge timing determined by treating physician per standard practice.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Early Discharge with Lasix® ONYU (furosemide injection, for subcutaneous use) using SQIN-Infusor","Each practice group randomized to early discharge with subcutaneous furosemide will provide the patient with prefilled units of Lasix® ONYU furosemide injection containing 80 mg per 2.67 mL in a single-dose prefilled cartridge co-packaged with a single-use Disposable Unit of the Infusor that will be used in conjunction with the reusable unit of the Lasix ONYU Infusor. Dosing based on pre-admission oral furosemide requirements: ≤80mg\u002Fday oral furosemide will be given 80mg subcutaneous once daily or \\>80mg\u002Fday oral furosemide will be given 80mg subcutaneous twice daily. Dosing will be continued until clinical euvolemia is reached.",[9],[26],"subcutaneous furosemide",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Ambarish Pandey, MD","CONTACT","214-645-2101","ambarish.pandey@utsouthwestern.edu",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Neil Keshvani, MD","214-6485198","neil.keshvani@utsouthwestern.edu",[38,50],{"facility":5,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":18},"Dallas","Texas","75209","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-96.80667,32.78306,{"lat":48,"lon":47},{"facility":51,"status":18,"city":39,"state":40,"zip":52,"country":42,"countryCode":43,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Baylor Scott and White Health System","75246",{"type":45,"coordinates":54},[47,48],{"lat":48,"lon":47},[57],{"name":34,"role":30,"phone":58,"phoneExt":18,"email":59},"214-384-9004","neil.keshvani@bswhealth.org",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ambarish Pandey","Associate Professor","100594350","phase-3-early-discharge-with-subcutaneous-furosemide-versus-standard-care-in-acute-heart-failure-100594350",false,"NCT07018297","Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure","Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure: A Cluster-Randomized Crossover Non-Inferiority Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Within 48 hours of inpatient stay OR ED presentation for HF with plans for admission OR observation stay\u002Fshort-stay hospitalization for HF\n* Expected to require at least 24 additional hours of IV diuretics\n* Adequate home environment for self-care\n* Patient or caregiver capable of operating subcutaneous delivery device\n\nExclusion Criteria:\n\n* Cognitive impairment preventing informed consent\n* Geographic barriers to follow-up\n* Pregnancy or breastfeeding\n* IV furosemide requirement \\>250mg\u002Fday\n* eGFR \\\u003C20 mL\u002Fmin\u002F1.73m2\n* Type 1 myocardial infarction during index admission\n* End-stage HF with receipt or consideration of heart transplant or LVAD or requiring inotropic or mechanical circulatory support\n* Potassium \\\u003C3.0 or \\>6.0 mmol\u002FL or sodium \\\u003C125 mmol\u002FL","ALL","18 Years","100 Years",{"count":75,"type":76},250,"ESTIMATED","INTERVENTIONAL",[79],"PHASE3","This will be a prospective, cluster-randomized, crossover, non-inferiority trial of 250 participants within 48 hours of an inpatient admission for heart failure or emergency department presentation for heart failure with plans for admission or observation\u002Fshort-stay hospitalization comparing early discharge using subcutaneous furosemide to standard inpatient care. Individual practice groups will serve as \"clusters\" and the unit of randomization. Each participating cluster will implement either the early discharge strategy using the intervention or standard care for initial two-month blocks, followed by a crossover to the alternate strategy. The primary outcome is days alive and out of hospital at 30 days.",[82,83],"Heart Failure","Acute Decompensated Heart Failure",[85,86,87,88],"Subcutaneous Furosemide","Length of Stay (LOS)","Hospitalization","Resource Allocation","NOT_YET_RECRUITING","2026-05-01",{"date":92,"type":93},"2026-05-04","ACTUAL",{"date":95,"type":76},"2026-08",{"date":97,"type":76},"2028-09-01",{"name":5,"class":6},2]