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Intravenous iron for heart failure, iron deficiency definitions, and clinical response: the IRONMAN trial

2024; Oxford University Press; Volume: 45; Issue: 16 Linguagem: Inglês

10.1093/eurheartj/ehae086

1522-9645

John G.F. Cleland, Philip A. Kalra, Pierpaolo Pellicori, Fraser J Graham, Paul W X Foley, Iain Squire, Peter J. Cowburn, Alison Seed, Andrew L. Clark, Ben Szwejkowski, Prithwish Banerjee, Justin Cooke, Mark Francis, Piers Clifford, Aaron Wong, Colin J. Petrie, John J.V. McMurray, Elizabeth Thomson, Kirsty Wetherall, Michele Robertson, Ian Ford, Paul R. Kalra, Paul R. Kalra, Elena Cowan, Charlotte Turner, Rosalynn Austin, Rebeca Lane, Paula Rogers, Paul Foley, Badri Chandrasekaran, Eva Fraile, Lynsey Kyeremeh, Fozia Ahmed, Mark C. Petrie, Lorraine McGregor, Joanna Osmanska, Fraser J Graham, Ninian N. Lang, Bernhard Meyer, Faheem Ahmad, Joanna Osmanska, Iain Squire, Jude Fisher, Philip A. Kalra, Christina Summersgill, Katarzyna Adeniji, Rajkumar Chinnadurai, Andrew Ludman, Lisa Massimo, Clare S. Hardman, Daisy Sykes, Peter J. Cowburn, Sarah Frank, Simon Smith, Alan G. Japp, Mohamed Anwar, Beth Whittington, Alison Seed, Robin Ray, Vennessa Sookhoo, Sinéad Lyons, Abdallah Al‐Mohammad, Janet Middle, Kay Housley, Andrew L. Clark, Jeanne Bulemfu, Christopher Critoph, Victor Chong, Stephen J. Wood, Benjamin R. Szwejkowski, Chim C. Lang, Jackie Duff, Susan M. MacDonald, Rebekah Schiff, John Donnelly, Thuraia Nageh, Swapna Kunhunny, Mark C. Petrie, Roy S. Gardner, Marion McAdam, Elizabeth McPherson, Prithwish Banerjee, Eleanor Sear, Nigel Edwards, Jason Glover, Pierpaolo Pellicori, Clare Murphy, Justin Cooke, Charles Spencer, Mark Francis, Iain Matthews, Hayley McKie, Andrew Marshall, Janet Large, Jenny Stratford, Piers Clifford, Christopher J. Boos, Philip J. Keeling, Aaron Wong, Deborah J. Jones, Alex James, Rhys Williams, Stephen J Leslie, Jim Finlayson, Piers Clifford, Andrew Hannah, Philip Campbell, John Walsh, Jane Quinn, Callum Chapman, Susan Piper, Sheetal Patale, Preeti Gupta, Victor Sim, Lucy Knibbs, Kristopher Lyons, Lana Dixon, Colin J. Petrie, Yuk-ki Wong, Catherine Labinjoh, Simon Duckett, Ian J. Massey, Henry Oluwasefunmi Savage, Sofia Matias, Jonaifah Ramirez, Charlotte Manisty, Ifza Hussain, Rajiv Sankaranarayanan, Gershan Davis, Samuel McClure, John Baxter, Eleanor Wicks, Jolanta Sobolewska, Jerry D. Murphy, Ahmed Elzayat, Jay Wright, Simon G. Williams, Amal Muthumala, Parminder S Chaggar, Sue Webber, Geraint Ellis, Mandie Welch, Sudantha Bulugahapitiya, Thomas Jackson, Tapesh Pakrashi, Ameet Bakhai, Srinivas Murthy, Reto Gamma, Susan Ellery, Charlotte Manisty, Geraint H. Jenkins, Angus K. Nightingale, Elizabeth Thomson, Ian Ford, Michele Robertson, Nicola Greenlaw, Kirsty Wetherall, Ross Clarke, Fraser J Graham, Sharon Kean, A. C. Stevenson, Robbie S. Wilson, Sarah C. Boyle, John B. McHugh, Lisa Hall, Joanne Woollard, Claire Brunton, Eleanor Dinnett, Amanda Reid, Serena Howe, Jill Nicholls, Anna Cunnington, Elizabeth Douglas, Margaret Fegen, Marc V. Jones, Sheila McGowan, Barbara Ross, Pamela Sandu, Pamela Surtees, Debra Stuart, Nicholas A. Boon, Shannon Amoils, Callum Chapman, John G.F. Cleland, Thomas Goldin Diness, Ian Ford, Paul R. Kalra, Philip A. Kalra, Iain C. Macdougall, John J.V. McMurray, Richard Mindham, Mark C. Petrie, Pamela Sandu, Iain Squire, Claes Christian Strom, Elizabeth Thomson, Maureen Travers, Robert Wilcox, Allan D. Struthers, Patrick B. Mark, Christopher J. Weir, John G.F. Cleland, Fraser J Graham, Pierpaolo Pellicori,

Heart Failure Treatment and Management

Abstract Background and Aims What is the relationship between blood tests for iron deficiency, including anaemia, and the response to intravenous iron in patients with heart failure? Methods In the IRONMAN trial, 1137 patients with heart failure, ejection fraction ≤ 45%, and either serum ferritin < 100 µg/L or transferrin saturation (TSAT) < 20% were randomized to intravenous ferric derisomaltose (FDI) or usual care. Relationships were investigated between baseline anaemia severity, ferritin and TSAT, to changes in haemoglobin from baseline to 4 months, Minnesota Living with Heart Failure (MLwHF) score and 6-minute walk distance achieved at 4 months, and clinical events, including heart failure hospitalization (recurrent) or cardiovascular death. Results The rise in haemoglobin after administering FDI, adjusted for usual care, was greater for lower baseline TSAT (Pinteraction < .0001) and ferritin (Pinteraction = .028) and more severe anaemia (Pinteraction = .014). MLwHF scores at 4 months were somewhat lower (better) with FDI for more anaemic patients (overall Pinteraction = .14; physical Pinteraction = .085; emotional Pinteraction = .043) but were not related to baseline TSAT or ferritin. Blood tests did not predict difference in achieved walking distance for those randomized to FDI compared to control. The absence of anaemia or a TSAT ≥ 20% was associated with lower event rates and little evidence of benefit from FDI. More severe anaemia or TSAT < 20%, especially when ferritin was ≥100 µg/L, was associated with higher event rates and greater absolute reductions in events with FDI, albeit not statistically significant. Conclusions This hypothesis-generating analysis suggests that anaemia or TSAT < 20% with ferritin > 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.