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Not yet taking people in United StatesPhase 4

Tests intravenous iron in older adults with heart failure and iron deficiency

Tests intravenous iron against saline placebo in older adults with heart failure and iron deficiency.

Key facts

Who runs it
Duke University
Where
Durham, United StatesSee the site
Trial code
Registry title
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
Status
Not yet recruiting
Phase
Phase 4
People taking part
300 people, planned
Started
Nov 2026
Expected to end
Aug 2030
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Ferric derisomaltose
  • Placebo (normal saline)
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 65 or older who have heart failure with preserved ejection fraction (EF above 50%) and low iron. It tests iron given through a vein against a placebo.

Age
65 years or older
Sex
All sexes can join.
Disease stage
Heart failure with preserved ejection fraction (EF >50%), living at home and not in hospital now, but hospitalized for heart failure in the past 12 months. Must be able to walk without assistance.
Earlier treatment
Cannot have used IV iron therapy now or in the last 4 weeks.
Biomarker or test result
TSAT below 20%.

Main reasons for not taking part

  • Another cause of the heart failure, such as uncorrected severe valve disease, constrictive pericarditis, high output heart failure or infiltrative cardiomyopathy
  • Allergy to any IV iron product, or history of iron overload such as hemochromatosis
  • Hemoglobin below 9 g/dL, or above 13.5 g/dL (women) or 15.0 g/dL (men)
  • Severe liver disease, severe kidney impairment (eGFR below 15) or dialysis, or life expectancy under 6 months
  • Pregnancy, breastfeeding or planned pregnancy during the study

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Ambulatory adults age >=65 years with HFpEF (EF >50%)
  • Hospitalized for HF in the past 12 months
  • TSAT <20%
  • Able to walk without assistance

Who cannot take part

  • Current or recent use (4 weeks) of IV iron therapy
  • Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline
  • Alternative etiologies of HFpEF syndrome:
  • Uncorrected severe valvular heart disease
  • Known hypersensitivity/allergy to any IV iron formulation
  • History of iron overload (i.e., hemochromatosis)
  • Active infection or inflammatory disease
  • Severe liver disease (i.e., active hepatitis or known cirrhosis)
  • Hemoglobin <9 g/dL or >13.5 (women)/>15.0 (men) g/dL
  • Severe renal impairment (i.e., eGFR <15 mL/min/1.73 m2 or Chronic Kidney Disease on dialysis)
  • Constrictive pericarditis
  • High output HF
  • Infiltrative cardiomyopathy
  • Safety concerns for participation
  • Hospitalized for GI bleed in past 12 months
  • Estimated life expectancy <6 months
  • Unable to provide informed consent
  • Pregnancy, breastfeeding, or planned pregnancy during the study period

Where in United States

  • Duke University Health SystemDurham, United StatesNot yet recruiting

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Ferric DerisomaltoseTreatment being tested
  • PlaceboPlacebo, for comparison

    Treatment: Placebo (normal saline)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
Plain-language title
Tests intravenous iron in older adults with heart failure and iron deficiencyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026