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IV Iron Therapy for Older Adults with Heart Failure and Iron Deficiency

This study is testing an intravenous (IV) iron treatment called ferric derisomaltose for older adults with a type of heart failure called Heart Failure with Preserved Ejection Fraction (HFpEF) and iron deficiency. HFpEF means your heart can pump blood, but it's too stiff to fill properly. You might be able to join if you are 65 or older, have HFpEF with an ejection fraction (EF) over 50%, have been hospitalized for heart failure in the past year, and have low iron levels (TSAT <20%). The study aims to see if ferric derisomaltose can reduce death, hospitalizations, and improve your quality of life over 6 months. This study is currently unclear about its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study involving 300 participants. This means participants will be randomly assigned to receive either the study drug or a placebo (inactive substance), and neither you nor your doctor will know which you are receiving.
What's involved
Participants will receive a single infusion of either ferric derisomaltose or a placebo. The primary outcomes will be measured at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for 6 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07686692

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

Not Yet Recruiting
PHASE4Ages 65+InterventionalTreatment
Duke University
~300 participants
Updated 2026-07-07 on ClinicalTrials.gov
What's tested:Ferric derisomaltosePlacebo (normal saline)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Measured over 6 months

Conditions

Heart Failure With Preserved Ejection Fraction
Iron Deficiency

Explore related trials

Heart failure with normal ejection fractionIron Deficiency

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Marat Fudim · PRINCIPAL_INVESTIGATOR · Duke University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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