IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07686692
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ferric derisomaltose — DRUG
    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.
  • Placebo (normal saline) — DRUG
    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.

Study Details

This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ferric Derisomaltose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Health SystemDurhamNorth Carolina27705-

Find similar trials in Durham, NC

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Duke University Health System· Durham, NC

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