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INFUSE-HFpEF
NCT07686692Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Aug 2030
- Countries
- 1
- Sponsor
- Duke University
- Drugs
- ferric derisomaltose
- Conditions
- heart failure with preserved ejection fraction (HFpEF)iron deficiency anemia (IDA)
01
Overview
Phase 4, randomised, double-blind trial in heart failure with preserved ejection fraction (HFpEF) and iron deficiency anemia (IDA) comparing Ferric Derisomaltose with Placebo (2 arms). Primary endpoint: Hierarchical composite of mortality, all-cause hospitalization, and >=5-point KCCQ-12 improvement at 6 months. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
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.
Placebo
Normal saline placebo dose is determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.
03
Who it enrols
Ambulatory adults >=65 years with HFpEF (EF >50%), hospitalized for HF in the past 12 months, with iron deficiency (TSAT <20%) and specific hemoglobin ranges, excluding those with severe renal or liver impairment, active infection, or recent IV iron use.
04
Endpoints
Primary
Hierarchical composite of mortality, all-cause hospitalization, and >=5-point KCCQ-12 improvement
Secondary
6-Minute Walk Test
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