Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency

Summary

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)

Timeline

Start

2017-04-03

Primary completion

2020-07-21

Completion

2020-07-21

Publications

• Rosano G, Ponikowski P, Vitale C, Anker SD, Butler J, Fabien V, Filippatos G, Kirwan BA, Macdougall IC, Metra M, Ruschitzka F, Kumpeson V, Goehring UM, van der Meer P, Jankowska EA; AFFIRM-AHF investigators. Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial. Cardiovasc Diabetol. 2023 Aug 17;22(1):215. doi: 10.1186/s12933-023-01943-z.
• Macdougall IC, Ponikowski P, Stack AG, Wheeler DC, Anker SD, Butler J, Filippatos G, Gohring UM, Kirwan BA, Kumpeson V, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA. Ferric Carboxymaltose in Iron-Deficient Patients with Hospitalized Heart Failure and Reduced Kidney Function. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1124-1134. doi: 10.2215/CJN.0000000000000223. Epub 2023 Jun 29.
• Filippatos G, Ponikowski P, Farmakis D, Anker SD, Butler J, Fabien V, Kirwan BA, Macdougall IC, Metra M, Rosano G, Ruschitzka F, van der Meer P, Wachter S, Jankowska EA; AFFIRM-AHF Investigators. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis. Circulation. 2023 May 30;147(22):1640-1653. doi: 10.1161/CIRCULATIONAHA.122.060757. Epub 2023 Apr 13.
• Ponikowski P, Kirwan BA, Anker SD, McDonagh T, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Gohring UM, Keren A, Khintibidze I, Kragten H, Martinez FA, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parkhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Lewis BS, Comin-Colet J, von Haehling S, Cohen-Solal A, Danchin N, Doehner W, Dargie HJ, Motro M, Butler J, Friede T, Jensen KH, Pocock S, Jankowska EA; AFFIRM-AHF investigators. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020 Dec 12;396(10266):1895-1904. doi: 10.1016/S0140-6736(20)32339-4. Epub 2020 Nov 13.
• Ponikowski P, Kirwan BA, Anker SD, Dorobantu M, Drozdz J, Fabien V, Filippatos G, Haboubi T, Keren A, Khintibidze I, Kragten H, Martinez FA, McDonagh T, Metra M, Milicic D, Nicolau JC, Ohlsson M, Parhomenko A, Pascual-Figal DA, Ruschitzka F, Sim D, Skouri H, van der Meer P, Jankowska EA. Rationale and design of the AFFIRM-AHF trial: a randomised, double-blind, placebo-controlled trial comparing the effect of intravenous ferric carboxymaltose on hospitalisations and mortality in iron-deficient patients admitted for acute heart failure. Eur J Heart Fail. 2019 Dec;21(12):1651-1658. doi: 10.1002/ejhf.1710. Epub 2019 Dec 28.

Drugs

Indications