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

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

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