[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587547":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Pharmacosmos A\u002FS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ferric Derisomaltose","EXPERIMENTAL","50 % of the subjects will be treated with Ferric Derisomaltose 100 mg\u002FmL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below \\\u003C25 %",[13],"Drug: Ferric Derisomaltose",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","50 % of the subjects will receive no IV iron",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"DRUG","100 mg\u002FmL",[9],[25],{"name":26,"affiliation":5,"role":27},"Pharmacosmos Clinical and non-clinical department","STUDY_DIRECTOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Pharmacosmos Clinical and non-clinical Department","CONTACT","+45 5948 5959","info@pharmacosmos.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Private clinic","RECRUITING","Pasadena","California","91105","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.14452,34.14778,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":18,"phoneExt":18,"email":18},"MD",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100587547","phase-3-multi-center-trial-of-ferric-derisomaltose-versus-no-intravenous-iron-in-iron-deficient-subjects-with-symptomatic-chronic-heart-failure-100587547",false,"NCT06929806","Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure","ICONIC-HF","Inclusion Criteria:\n\n* 18 years or older\n* Both women and men can join\n* Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity\n* Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less\n* Have low iron levels in the blood\n* New York Heart Association (NYHA) Heart Failure Classification II, III or IV\n\nExclusion Criteria:\n\n* Planned cardiac surgery or revascularization or cardiac device implantation\n* Pregnant or nursing women\n* Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months\n* Treatment with radiotherapy or chemotherapy","ALL","18 Years",{"count":65,"type":66},1900,"ESTIMATED","INTERVENTIONAL",[69],"PHASE3","The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:\n\n• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels\n\nResearchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.\n\nParticipants will:\n\n* Be randomized 50\u002F50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose\n* All participants receives standard of care\n* Visit site 4-5 times and have 7 video\u002Fphone-calls",[72,73],"Chronic Heart Failure","Iron Deficiencies","2025-07-17",{"date":76,"type":77},"2025-07-23","ACTUAL",{"date":79,"type":77},"2025-05-01",{"date":81,"type":66},"2027-12-01",{"name":5,"class":6},1]