[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646759":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":11,"locations":33,"responsibleParty":47,"collaborators":49,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ferric Derisomaltose","EXPERIMENTAL",null,[13],"Drug: Ferric derisomaltose",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo (normal saline)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Ferric derisomaltose","Intravenous ferric derisomaltose dose is determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo (normal saline)","To preserve blinding, the normal saline placebo dose is also determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.",[15],[30],{"name":31,"affiliation":5,"role":32},"Marat Fudim","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":11,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":11},"Duke University Health System","Durham","North Carolina","27705","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-78.89862,35.99403,{"lat":45,"lon":44},{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[50,53,55],{"name":51,"class":52},"National Institutes of Health (NIH)","NIH",{"name":54,"class":52},"National Institute on Aging (NIA)",{"name":56,"class":6},"Kaiser Permanente","100646759","phase-4-iv-iron-therapy-for-older-adults-with-heart-failure-with-preserved-ejection-fraction-and-iron-deficiency-100646759",false,"NCT07686692","IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency","Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction","INFUSE-HFpEF","Inclusion Criteria:\n\n* Ambulatory adults age \\>=65 years with HFpEF (EF \\>50%)\n* Hospitalized for HF in the past 12 months\n* TSAT \\\u003C20%\n* Able to walk without assistance\n\nExclusion Criteria:\n\n* Alternative etiologies of HFpEF syndrome:\n* Uncorrected severe valvular heart disease\n* Constrictive pericarditis\n* High output HF\n* Infiltrative cardiomyopathy\n* Safety concerns for participation\n* Known hypersensitivity\u002Fallergy to any IV iron formulation\n* History of iron overload (i.e., hemochromatosis)\n* Hemoglobin \\\u003C9 g\u002FdL or \\>13.5 (women)\u002F\\>15.0 (men) g\u002FdL\n* Hospitalized for GI bleed in past 12 months\n* Active infection or inflammatory disease\n* Severe liver disease (i.e., active hepatitis or known cirrhosis)\n* Current or recent use (4 weeks) of IV iron therapy\n* Severe renal impairment (i.e., eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m2 or Chronic Kidney Disease on dialysis)\n* Estimated life expectancy \\\u003C6 months\n* Unable to provide informed consent\n* Pregnancy, breastfeeding, or planned pregnancy during the study period\n* Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline","ALL","65 Years",{"count":68,"type":69},300,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.",[75,76],"Heart Failure With Preserved Ejection Fraction","Iron Deficiency",[78,76,9],"Heart Failure with Preserved Ejection Fraction","NOT_YET_RECRUITING","2026-06-30",{"date":82,"type":83},"2026-07-07","ACTUAL",{"date":85,"type":69},"2026-08",{"date":87,"type":69},"2030-08",{"name":5,"class":6},1]