[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":50,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital Southampton NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IRONHEART Observational Study Group",null,"16 participants, with non-ischaemic heart failure, with iron deficiency TSATS \\\u003C20% and heart failure with a reduced ejection fraction \\\u003C40%.\n\nCohort will have to be established on guideline directed heart failure therapy. Participants meeting eligibility criteria will undergo baseline quality of life questionnaires, hand grip tests and six minute walk tests before receiving intravenous iron derisomaltose and repeating these investigations again after 24 hours and 30 days including a cardiac magnetic resonance imaging.",[13],"Drug: Ferric derisomaltose",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Ferric derisomaltose","See group descriptions",[9],[21],{"name":22,"affiliation":5,"role":23},"Andrew S Flett, MBBS BSc MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Flett","CONTACT","+442381205906","andrew.flett@uhs.nhs.uk",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Rachael Pulham","+442381205044","sponsor@uhs.nhs.uk",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Southampton","Hampshire","SO16 6YD","United Kingdom","UK",{"type":43,"coordinates":44},"Point",[45,46],-1.40428,50.90395,{"lat":46,"lon":45},[49],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[53],{"name":54,"class":55},"Portsmouth Hospitals NHS Trust","OTHER_GOV","100557800","ironheart-intravenous-iron-in-non-ischaemic-heart-failure-100557800",false,"NCT06542822","IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure","Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study","IRONHEART","Inclusion Criteria:\n\n* Participants capable of giving informed consent.\n* Aged 18yrs and above.\n* Diagnosed with heart failure and a reduction of their ejection fraction \\\u003C 40% by any modality.\n* Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.\n* Iron deficient per this definition: Transferrin saturations \\\u003C 20%.\n* Established on Heart failure therapy including SGLT2i therapy for a minimum of four weeks prior to recruitment.\n* New York Heart Association score of I - III class.\n\nExclusion Criteria:\n\n* New York Heart Association classification Score \\>IV\n* Ischaemic cardiomyopathy\n* Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30\n* Requirement for renal dialysis\n* Atrial fibrillation \u002F atrial flutter\n* Non cardiac and cardiac palliative diagnosis\n* Active cancer diagnosis\n* Moderate to severe valvular heart disease\n* Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device\n* Cardiac \\& non cardiac transplant participants\n* Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days\n* Complex congenital heart disease\n* Pregnancy","ALL","18 Years",{"count":67,"type":68},16,"ESTIMATED","OBSERVATIONAL","The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF\\\u003C40%), iron deficiency (TSATS\\\u003C20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.",[72,73],"Heart Failure","Iron Deficiencies",[17,75,76,77,78,79,80,81],"Non-ischaemic heart failure","Chronic heart failure","Iron deficiency","Left ventricular failure","Iron homeostasis","Cardiac MRI","Cardiac Magnetic resonance imaging","2024-08-05",{"date":84,"type":85},"2024-08-07","ACTUAL",{"date":87,"type":85},"2024-04-15",{"date":89,"type":68},"2027-02",{"name":5,"class":6},1]