[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07686692":3,"trial-entities:NCT07686692":96,"trial-summary:NCT07686692":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":46,"sex":49,"minimum_age":50,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":77,"locations":79,"central_contacts":89,"overall_officials":90,"references":94,"see_also_links":95},"NCT07686692","Pro00119548","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","NOT_YET_RECRUITING","2030-08","2026-06","2026-07-07","2026-08","Duke University","OTHER",false,"This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.",null,[19,20],"Heart Failure With Preserved Ejection Fraction","Iron Deficiency",[22,20,23],"Heart Failure with Preserved Ejection Fraction","Ferric Derisomaltose","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},300,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"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.",[23],{"type":33,"name":38,"description":39,"armGroupLabels":40},"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.",[41],"Placebo",[43],{"measure":44,"timeFrame":45},"Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.","6 months",[47],{"measure":48,"timeFrame":45},"6-MWT","ALL","65 Years",{"inclusion":52,"exclusion":57,"raw_text":76},[53,54,55,56],"Ambulatory adults age \\>=65 years with HFpEF (EF \\>50%)","Hospitalized for HF in the past 12 months","TSAT \\\u003C20%","Able to walk without assistance",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"Alternative etiologies of HFpEF syndrome:","Uncorrected severe valvular heart disease","Constrictive pericarditis","High output HF","Infiltrative cardiomyopathy","Safety concerns for participation","Known hypersensitivity\u002Fallergy to any IV iron formulation","History of iron overload (i.e., hemochromatosis)","Hemoglobin \\\u003C9 g\u002FdL or \\>13.5 (women)\u002F\\>15.0 (men) g\u002FdL","Hospitalized for GI bleed in past 12 months","Active infection or inflammatory disease","Severe liver disease (i.e., active hepatitis or known cirrhosis)","Current or recent use (4 weeks) of IV iron therapy","Severe renal impairment (i.e., eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m2 or Chronic Kidney Disease on dialysis)","Estimated life expectancy \\\u003C6 months","Unable to provide informed consent","Pregnancy, breastfeeding, or planned pregnancy during the study period","Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline","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",[78],"OLDER_ADULT",[80],{"facility":81,"city":82,"state":83,"zip":84,"country":85,"geoPoint":86},"Duke University Health System","Durham","North Carolina","27705","United States",{"lat":87,"lon":88},35.99403,-78.89862,[],[91],{"name":92,"affiliation":13,"role":93},"Marat Fudim","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98,20],"Heart failure with normal ejection fraction",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a randomized, double-blind, placebo-controlled study involving 300 participants. This means participants will be randomly assigned to receive either the study drug or a placebo (inactive substance), and neither you nor your doctor will know which you are receiving.","completed","IV Iron Therapy for Older Adults with Heart Failure and Iron Deficiency","This study is testing an intravenous (IV) iron treatment called ferric derisomaltose for older adults with a type of heart failure called Heart Failure with Preserved Ejection Fraction (HFpEF) and iron deficiency. HFpEF means your heart can pump blood, but it's too stiff to fill properly. You might be able to join if you are 65 or older, have HFpEF with an ejection fraction (EF) over 50%, have been hospitalized for heart failure in the past year, and have low iron levels (TSAT \u003C20%). The study aims to see if ferric derisomaltose can reduce death, hospitalizations, and improve your quality of life over 6 months. This study is currently unclear about its recruitment status.","Your health will be monitored for 6 months after the treatment.",114,"Participants will receive a single infusion of either ferric derisomaltose or a placebo. The primary outcomes will be measured at 6 months.","Not stated in the trial record.",[34],"v2"]