IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
Starting soon · Phase 4 · Has a placebo group
Conditions studied: Heart Failure With Preserved Ejection Fraction, Iron Deficiency
In brief
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Key facts
- Study ID
- NCT07686692
- Run by
- Duke University
- People needed
- 300
- Starts
- 2026-08-01
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ambulatory adults age >=65 years with HFpEF (EF >50%)
- Hospitalized for HF in the past 12 months
- TSAT <20%
- Able to walk without assistance
You may not qualify if…
- 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
Where it is running
- Duke University Health System — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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