Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
Duke University
Summary
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ambulatory adults age \>=65 years with HFpEF (EF \>50%) * Hospitalized for HF in the past 12 months * TSAT \<20% * Able to walk without assistance Exclusion Criteria: * Alternative etiologies of HFpEF syndrome: * Uncorrected severe valvular heart disease * Constrictive pericarditis * High output HF * Infiltrative cardiomyopathy * Safety concerns for participation * Known hypersensitivity/allergy to any IV iron formulation * History of iron overload (i.e., hemochromatosis) * Hemoglobin \<9 g/dL or \>13.5 (women)/\>15.0 (men) g/dL * Hospitalized for GI bleed in past 12 m…
Interventions
- DrugFerric 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.
- DrugPlacebo (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.
Location
- Duke University Health SystemDurham, North Carolina