[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557239":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":34,"locations":44,"responsibleParty":61,"collaborators":33,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":33,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":33,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Helwan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acetazolamide + Standard Care","ACTIVE_COMPARATOR","Participants in this arm will receive:\n\n1. Acetazolamide: 500 mg orally, once daily for 3 days\n2. Intravenous loop diuretics: Administered at double the oral maintenance dose, given as follows:\n\n   * Initial dose: Single bolus immediately after randomization\n   * Subsequent doses: Split into two or more doses (separated by ≥6 hours) on each of the next 2 days The specific loop diuretic used (e.g., furosemide) will be determined by the treating physician based on the patient's prior medication regimen and clinical status.",[13],"Drug: Acetazolamide",{"label":15,"type":10,"description":16,"interventionNames":17},"Dapagliflozin + Standard Care","Participants in this arm will receive:\n\n1. Dapagliflozin: 10 mg orally, once daily for 3 days\n2. Intravenous loop diuretics: Administered as described in Arm 1",[18],"Drug: Dapagliflozin 10mg",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Acetazolamide","Patients will receive acetazolamide 500 mg once daily for 3 days as add on therapy to IV loop diuretics",[9],[26],"Cidamix",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Dapagliflozin 10mg","patient will receive oral dapagliflozin 10 mg once daily for 3 days as add on therapy to IV loop diuretics",[15],[32],"Forxiga",null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Nouran Mo Anwar, Bachelor","CONTACT","01124119559","Nouran.Anwar@pharm.helwan.edu.eg",{"name":41,"role":37,"phone":42,"phoneExt":33,"email":43},"Mahmoud I Mostafa, PhD","01006605563","Mahmoud.ibrahim@pharma.helwan.edu.eg",[45],{"facility":46,"status":47,"city":48,"state":33,"zip":33,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Critical Care Medicine Department - Cairo University Hospitals.","RECRUITING","Cairo","Egypt","EG",{"type":52,"coordinates":53},"Point",[54,55],31.24967,30.06263,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":38,"phoneExt":33,"email":60},"Nouran M Anwar",".Nouran.Anwar@pharm.helwan.edu.eg",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Mahmoud I Mostafa","Lecturer of Clinical Pharmacy.Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Helwan University, Cairo, Egypt.","100557239","phase-3-acetazolamide-versus-dapagliflozin-in-acute-decompensated-heart-failure-patients-100557239",false,"NCT06535529","Acetazolamide Versus Dapagliflozin in Acute Decompensated Heart Failure Patients","Inclusion Criteria:\n\n* Male or female patients of 18 years of age or older.\n* An elective or emergency hospital admission with clinical diagnosis of decompensated HF with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).\n* Assessed LVEF by any imaging technique; i.e. echocardiography, catheterization, nuclear scan magnetic resonance imaging within 12 months of inclusion.\n\nExclusion Criteria:\n\n* The receipt of acetazolamide maintenance therapy.\n* Receipt of an SGLT2 inhibitor in the 48 hours before randomization.\n* An estimated glomerular filtration rate (eGFR) \\\u003C20 mL\u002Fmin\u002F1.73 m2.\n* Use of any non-protocol defined diuretic agent with the exception of mineralocorticoid receptor antagonists during the treatment phase of the study. Thiazides, metolazone, indapamide and amiloride should be stopped upon study inclusion. If patient is taking a combination drug including a thiazide-type diuretic, the thiazide-type diuretic should be stopped.","ALL","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","The goal of this clinical trial is to compare the effectiveness of acetazolamide versus dapagliflozin as an add-on in treating acute decompensated heart failure (ADHF) in adult patients with clinical signs of volume overload requiring intravenous loop diuretics. It will also assess the safety of these drugs when added to standard care. The main questions it aims to answer are:\n\n* Does acetazolamide or dapagliflozin lead to a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels?\n* Which drug results in better loop diuretic efficiency, as measured by weight loss per 40 mg of intravenous furosemide or equivalent? We will compare acetazolamide to dapagliflozin, both added to standard intravenous loop diuretic therapy, to see which is more effective in decongesting patients with ADHF.\n\nParticipants will:\n\n* Take either acetazolamide or dapagliflozin orally every day for 3 days\n* Receive intravenous loop diuretics as part of standard care\n* Undergo regular assessments of heart failure symptoms, weight, and laboratory tests\n* Be followed up until hospital discharge and for 30 days after starting the study",[81],"Acute Decompensated Heart Failure",[83,84,22,85,86],"Acute Heart failure","ADHF","SGLT2 inhibitors","SGLT2i","2024-08-01",{"date":89,"type":90},"2024-08-05","ACTUAL",{"date":92,"type":75},"2024-08-24",{"date":94,"type":75},"2025-09-01",{"name":5,"class":6},1]