IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency (INFUSE-HFpEF)

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