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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07686692

Acronym

INFUSE-HFpEF

Enrollment

300

Registered

2026-07-07

Start date

2026-08-01

Completion date

2030-08-01

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction, Iron Deficiency

Keywords

Heart Failure with Preserved Ejection Fraction, Iron Deficiency, Ferric Derisomaltose

Brief summary

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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 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 \<15 mL/min/1.73 m2 or Chronic Kidney Disease on dialysis) * Estimated life expectancy \<6 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

Design outcomes

Primary

Measure	Time frame
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.	6 months

Secondary

Measure	Time frame
6-MWT	6 months

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarat Fudim

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026