Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

Summary

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Timeline

Start

2017-03-15

Primary completion

2023-02-02

Completion

2023-02-02

Publications

• Lewis GD, Giczewska A, Mentz RJ, Butler J, Ezekowitz JA, De Pasquale C, O'Meara E, Troughton RW, Ponikowski P, Wong YW, Ikoma T, Malhotra R, Blackman N, Rockhold FW, Hernandez AF; HEART-FID Trial Investigators. Functional and Prognostic Implications of Different Iron Deficiency Definitions in Heart Failure: Insights From HEART-FID. JACC Heart Fail. 2025 Dec;13(12):102661. doi: 10.1016/j.jchf.2025.102661. Epub 2025 Oct 25.
• Ezekowitz JA, Mulder H, Mentz RJ, Butler J, DE Pasquale CG, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Numan S, Blackman N, Rockhold FW, Hernandez AF. Prediction and Longer-Term Outcomes of All-cause and Cardiovascular Mortality in the HEART-FID Trial. J Card Fail. 2025 Dec;31(12):1822-1833. doi: 10.1016/j.cardfail.2025.01.009. Epub 2025 Jan 29.
• Harrington J, Mentz RJ, Rockhold FW, Garg J, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Storie T, Blackman N, Hernandez AF. Hierarchical End Points in Prior Heart Failure Trials and the HEART-FID Trial. Circ Heart Fail. 2024 Feb;17(2):e010676. doi: 10.1161/CIRCHEARTFAILURE.123.010676. Epub 2024 Jan 22.
• Mentz RJ, Garg J, Rockhold FW, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, She L, Harrington J, Adamczyk R, Blackman N, Hernandez AF; HEART-FID Investigators. Ferric Carboxymaltose in Heart Failure with Iron Deficiency. N Engl J Med. 2023 Sep 14;389(11):975-986. doi: 10.1056/NEJMoa2304968. Epub 2023 Aug 26.
• Harrington J, Mentz RJ, Rockhold FW, Garg J, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Blackman N, Hernandez AF. Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial. Am Heart J. 2023 Dec;266:25-31. doi: 10.1016/j.ahj.2023.08.005. Epub 2023 Aug 19.
• Mentz RJ, Ambrosy AP, Ezekowitz JA, Lewis GD, Butler J, Wong YW, De Pasquale CG, Troughton RW, O'Meara E, Rockhold FW, Garg J, Samsky MD, Leloudis D, Dugan M, Mundy LM, Hernandez AF; HEART-FID Trial Investigators. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design. Circ Heart Fail. 2021 May;14(5):e008100. doi: 10.1161/CIRCHEARTFAILURE.120.008100. Epub 2021 May 18.

Drugs

Indications