[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549438":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":52,"centralContacts":56,"locations":61,"responsibleParty":84,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":51,"enrollmentInfo":101,"targetDuration":51,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":117,"whyStopped":51,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"ferric carboxymaltose + SGLT2 inhibitor","EXPERIMENTAL","Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.",[13,14],"Drug: Iron Carboxymaltose","Drug: Dapagliflozin 10mg Tab",{"label":16,"type":17,"description":18,"interventionNames":19},"ferric carboxymaltose + placebo of SGLT2 inhibitor","ACTIVE_COMPARATOR","Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.",[13,20],"Drug: Placebo of Dapagliflozin",{"label":22,"type":23,"description":24,"interventionNames":25},"Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor","PLACEBO_COMPARATOR","Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.",[26,20],"Drug: Placebo of Iron Carboxymaltose",[28,35,41,47],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Iron Carboxymaltose","Iron Carboxymaltose 500 mg. 2 vials administered IV.",[9,16],[34],"Ferinject",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Dapagliflozin 10mg Tab","Dapagliflozin 10mg Tab, PO, onde a day.",[9],[40],"Forxiga",{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Placebo of Iron Carboxymaltose","Solution Sodium Chloride 0,9% 100 ml, IV, once.",[22],[46],"Saline",{"type":29,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Placebo of Dapagliflozin","Equal shape and appearance tab as the tab containing Dapagliflozin 10 mg",[22,16],null,[53],{"name":54,"affiliation":5,"role":55},"LUIS BECK DA SILVA, MD ScD","PRINCIPAL_INVESTIGATOR",[57],{"name":54,"role":58,"phone":59,"phoneExt":51,"email":60},"CONTACT","55 51 997330870","lbneto@hcpa.edu.br",[62],{"facility":63,"status":51,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","90450120","Brazil","BR",{"type":70,"coordinates":71},"Point",[72,73],-51.23019,-30.03283,{"lat":73,"lon":72},[76,80],{"name":77,"role":58,"phone":78,"phoneExt":51,"email":79},"Ana Paula Silveira, BMD","55 51 33596223","apbsilveira@hcpa.edu.br",{"name":81,"role":58,"phone":82,"phoneExt":51,"email":83},"Marcia Raymundo","55 51 33596224","mraymundo@hcpa.edu.br",{"type":55,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Luis Beck Da Silva Neto","Professor of Medicine",[88],{"name":89,"class":90},"Vifor Pharma","INDUSTRY","100549438","phase-3-iv-iron-and-sglt2-inhibitor-on-ventricular-function-and-myocardial-iron-content-in-heart-failure-with-iron-deficiency-100549438",false,"NCT06434025","IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency","Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.","COMBINED-HF","Inclusion Criteria:\n\n1. Age 18 years or over;\n2. Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;\n3. Serum ferritin \\\u003C100 µg\u002FL or serum ferritin between 100 and 299 µg\u002FL and transferrin saturation \\\u003C20%;\n4. Serum hemoglobin between 9.5 and 13.5 mg\u002FdL;\n5. Patients must be SGLT2 naive;\n6. Informed consent form (ICF) signed.\n\nExclusion Criteria:\n\n1. Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;\n2. Severe primary valve disease;\n3. Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;\n4. Patients already being treated for some type of non-iron deficiency anemia;\n5. Blood transfusion within 30 days prior to CMR examination;\n6. Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;\n7. Diagnosis of hemochromatosis.","ALL","18 Years",{"count":102,"type":103},99,"ESTIMATED","INTERVENTIONAL",[106],"PHASE3","Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.\n\nThis study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.",[109,110],"Heart Failure, Systolic","Iron Deficiencies",[112,113,114,115,116],"heart failure","iron deficiency","SGLT2 inhibitor","intravenous iron","clinical trial","NOT_YET_RECRUITING","2024-05-30",{"date":120,"type":121},"2024-06-03","ACTUAL",{"date":123,"type":103},"2024-05-24",{"date":125,"type":103},"2026-11-24",{"name":5,"class":6},1]