Outline of ongoing trials & major publications assessing effects of treatment of iron deficiency in chronic heart failure.

Intravenous Iron in Patients With Systolic Heart Failure and Iron Deficiency to Improve Morbidity & Mortality. FAIR-HF2, (n=1200) (NCT03036462)

HF, confirmed iron deficiency, Hb 9.5-14.0 g/dL

FCM (1,000 mg, then 500- 1,000 mg within 4 weeks [max 2,000 mg total], then 500 mg every 4 months

HF hospitalizations and CV death (composite endpoint)

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency. HEART-FID, NCT03037931 (n=3014)

NYHA II-IV, LVEF ≤35% or LVEF ≤25% in prior 2 years, Hb >9.0 g/dL and <13.5 g/dL (F) or <15.0 g/dL (M), ferritin <100 µg/L or 100 – 299 µg/L with TSAT <20%, either HFH within 12 months or elevated NP

FCM (2 doses of 15 mg/kg to a max. individual dose of 750 mg 7 days apart and a maxi combined dose of 1,500 mg, repeated every 6 months) vs placebo

Death and HFH at 1 year, and change in 6MWD at 6 months

Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomized, Open-label Multicenter Trial. IRONMAN, NCT02642562 (n=1299)

NYHA II-IV, LVEF <45%, Hb ≥9.0 g/dL and ≤13.0 g/dL (F) or ≤14.0 g/dL (M), ferritin <100 µg/L and/or TSAT <20% (with ferritin ≤ 400 µg/L), either HFH in 6 months or elevated NP

Iron isomaltoside (doses based on weight and Hb) vs “usual care”

CV mortality or HFH

Effect of IV Iron (Ferric Carboxymaltose) on Exercise Tolerance, Symptoms and Quality of Life in Patients With HFpEF and Iron Deficiency With and Without Anemia. FAIR-HFpEF, NCT03074591 (n=200)

HF with preserved LVEF (HFpEF) and diastolic dysfunction, LVEF ≥45%, NYHA II-III, either HFH within 1 year or elevated NP, Hb >9.0 g/dL and ≤14.0 g/dL, ferritin <100 µg/L or ferritin 100-299 with TSAT <20%, 6MWD <450 m

FCM vs placebo

Exercise capacity: change in 6MWD from baseline to 12 months