[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dapagliflozin-forxiga\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dapagliflozin-forxiga":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100567453","phase-4-sodium-glucose-cotransporter-2-inhibitors-for-repaired-tetralogy-of-fallot-patients-for-enhancement-of-cardio-pulmonary-status-trial-100567453",false,"NCT06668389","Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial","Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)","STEPS","Inclusion Criteria:\n\n* rTOF\n* Aged 18 years or above\n* Voluntarily agrees to participate in the clinical trial and provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure with reduced ejection fraction (HFrEF) with LVEF \\\u003C 40%\n* Planned cardiac and\u002For non-cardiac surgery in 3 months\n* Chronic kidney disease stages 4 to 5\n* Unable to perform cardiopulmonary test\n* Recent use of SGLT2 inhibitors within 6 months\n* Known hypersensitivity to SGLT2 inhibitors\n* History of diabetic ketoacidosis\n* Recent symptomatic hypoglycaemia within 6 months\n* Insulin dependent diabetes mellitus\n* History of perineum infection\n* Recent urinary tract infection within 6 months\n* Recent genital infection within 6 months\n* Other known contraindication to SGLT2 inhibitor\n* Pregnancy or breast feeding","ALL","18 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood. One sequalae that nearly all rTOF patients develop during their lifetime is significant pulmonary regurgitation. Pulmonary regurgitation causes progressive right ventricular dilatation and systolic dysfunction, which in turn impairs cardio-pulmonary function and overall survival.\n\nThere is currently no pharmacological therapy proven to improve cardio-pulmonary function in rTOF patients. In a double-blind, placebo controlled, randomized controlled trial involving 33 rTOF patients, the use of beta-adrenergic receptor blocker Bisoprolol failed to improve maximal oxygen uptake (VO2 max) in the treatment group. Furthermore, there was no significant change in dimension of right ventricle on cardiac imaging, or heart failure biomarkers including brain natriuretic peptide (BNP) and atrial natriuretic peptide (ANP). In the APPROPRIATE trial involving 64 patients, angiotensin-converting-enzyme inhibitor (ACEI) Ramipril similarly failed to improve VO2 max despite an improved right ventricular long-axis shortening. In REDEFINE trial, 95 rTOF patients were randomized in to receive angiotensin receptor blocker (ARB) Losartan and control. At the end of study, there was no significant difference between the two groups in VO2 max, right ventricular ejection fraction, and other key outcomes.\n\nSodium-glucose cotransporter 2 (SGLT2) inhibitor is a promising therapy for rTOF patients. Clinical trials consistently demonstrated that SGLT2 inhibitors reduce heart failure hospitalization and mortality among patients with heart failure with or without diabetes mellitus. There have been growing body of evidence that demonstrate that SGLT2 inhibitors improve right ventricular function. In a preclinical study of rat with pulmonary hypertension induced right ventricular failure, empagliflozin was found to reduce pulmonary pressure, alleviate right ventricular hypertrophy and reduce myocardial fibrosis. In a pilot study involving 10 patients with adult congenital heart disease and systemic right ventricular failure, SGLT2 inhibitors improved cardio-pulmonary function as reflected by 6-minute walk test performance and New York Heart Association functional status. Most recently, investigators from DAPA-SERVE randomized controlled trial reported that among 92 patients with systemic right ventricular failure, those randomized to receive SGLT2 inhibitors had superior systemic right ventricular function with larger fractional area change (FAC) and more negative free-wall global longitudinal strain. Nevertheless, as these trials involve patients with right ventricular connections to the systemic circulation rather than pulmonary circulation in rTOF, it is uncertain whether the trial results can be extrapolated to the rTOF population. The critical knowledge gap our proposed randomized controlled trial seeks to address is whether SGLT2 inhibitors improve cardio-pulmonary function in rTOF patients.",[27,28,29,30,31],"Congenital Heart Disease","Repaired Tetralogy of Fallot (rTOF)","Pulmonary Regurgitation","Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor","Dapagliflozin (Forxiga)",[27,28,29,33,31],"Sodium-glucose cotransporter 2 (SGLT2) inhibitor","RECRUITING","2025-05-19",{"date":37,"type":38},"2025-05-20","ACTUAL",{"date":40,"type":38},"2025-05-12",{"date":42,"type":21},"2026-12-31",{"name":44,"class":45},"The University of Hong Kong","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100573759","phase-3-dapagliflozin-versus-dexamethasone-role-in-pre-operative-management-of-non--diabetic-brain-tumor-patients-100573759","NCT06750458","Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients","Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients","Inclusion Criteria:\n\n* Males \\& females.\n* Age: between 18 and 75 years old.\n* Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:\n\n  * The initial clinical examination.\n  * Magnetic resonance imaging of the brain (MRI) with contrast.\n\nExclusion Criteria:\n\n* Age: \\> 75 years old, and \\\u003C18 years old.\n* Breast feeding female. • Pregnant female.\n* eGFR\\\u003C 30 mL\u002Fminute\u002F1.73 m2.\n* Patients with diabetes mellitus.\n* Patients with diabetic ketoacidosis.\n* Patients with urinary tract infection.\n* Dehydrated patients till normalized.\n* Lower limb amputation patients.\n* SGLT2 inhibitors hypersensitivity.\n* Severe hepatic patients (child-plug score class-c).","75 Years",{"count":56,"type":21},75,[58],"PHASE3","The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.",[61,31,62],"Glioma","Dexamethasone","NOT_YET_RECRUITING","2025-04-20",{"date":66,"type":38},"2025-04-22",{"date":68,"type":21},"2025-08-20",{"date":70,"type":21},"2026-12-20",{"name":72,"class":45},"Tanta University",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100574486","phase-1-dapagliflozin-on-outcomes-of-rhythm-control-strategy-pharmacological--interventional-in-patient-with-atrial-fibrillation-100574486","NCT06759909","Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation","Influence of Use of Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation","Inclusion Criteria:\n\n* Newly diagnosed AF patients (Time between AF diagnosis to rhythm control attempt less than one year) Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, Holter monitor (episodes of AF must be \\>30 seconds in duration to qualify as an inclusion criterion) Age of 18 years or older on the date of consent. Informed Consent\n\nExclusion Criteria:\n\n* Long standing persistent AF. Previous use of dapagliflozin within one month of rhythm control attempt. Previous rhythm control attempt. AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery). History of congestive heart failure. Active intracardiac thrombus Pre-existing pulmonary vein stenosis or pulmonary vein stent Contraindication to anticoagulation or radio contrast materials",true,{"count":82,"type":21},100,[84],"PHASE1","Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.",[31,87],"Atrial Fibrillation (AF)",[89,90],"dapagliflozin","rythme control","2025-01-03",{"date":93,"type":38},"2025-01-06",{"date":91,"type":21},{"date":96,"type":21},"2028-12-22",{"name":98,"class":45},"Assiut University"]