This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
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.
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.
Duke University Health System
Durham, North Carolina, United States
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Time frame: 6 months
6-MWT
Time frame: 6 months
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