IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches

Summary

The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent. The main questions the study will answer are: 1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks? 2. Does IV iron improve symptoms and quality of life more than oral iron? 3. How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality? Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better. What participants will do * Be randomly assigned by (like flipping a coin) to IV iron or oral iron. * Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks. * Visit the infusion clinic at 6 weeks for second dose of IV iron if needed. * Visit the clinic at 12 weeks for a follow-up to gather follow-up data including 1. A 6-minute walk test 2. Brief symptom and quality-of-life surveys 3. Blood tests to measure serum iron, ferritin, and transferrin saturation This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.

Timeline

Start

2025-04-02

Primary completion

2026-03-31

Completion

2026-03-31

Publications

• Results von Haehling S, Doehner W, Evertz R, Garfias-Veitl T, Derad C, Diek M, Karakas M, Birkemeyer R, Fillippatos G, Lainscak M, Butler J, Ponikowski P, Bohm M, Friede T, Anker SD. Ferric carboxymaltose and exercise capacity in heart failure with preserved ejection fraction and iron deficiency: the FAIR-HFpEF trial. Eur Heart J. 2024 Oct 5;45(37):3789-3800. doi: 10.1093/eurheartj/ehae479.
• Results Alcaide-Aldeano A, Garay A, Alcoberro L, Jimenez-Marrero S, Yun S, Tajes M, Garcia-Romero E, Diez-Lopez C, Gonzalez-Costello J, Mateus-Porta G, Cainzos-Achirica M, Enjuanes C, Comin-Colet J, Moliner P. Iron Deficiency: Impact on Functional Capacity and Quality of Life in Heart Failure with Preserved Ejection Fraction. J Clin Med. 2020 Apr 22;9(4):1199. doi: 10.3390/jcm9041199.
• Results Bekfani T, Pellicori P, Morris D, Ebner N, Valentova M, Sandek A, Doehner W, Cleland JG, Lainscak M, Schulze PC, Anker SD, von Haehling S. Iron deficiency in patients with heart failure with preserved ejection fraction and its association with reduced exercise capacity, muscle strength and quality of life. Clin Res Cardiol. 2019 Feb;108(2):203-211. doi: 10.1007/s00392-018-1344-x. Epub 2018 Jul 26.
• Results Cleland JGF, Pellicori P, Graham FJ, Lane R, Petrie MC, Ahmed F, Squire IB, Ludman A, Japp A, Al-Mohammad A, Clark AL, Szwejkowski B, Critoph C, Chong V, Schiff R, Nageh T, Glover J, McMurray JJV, Thomson EA, Robertson M, Ford I, Kalra PA, Kalra PR; IRONMAN Study Group. Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure. J Am Coll Cardiol. 2024 Oct 29;84(18):1704-1717. doi: 10.1016/j.jacc.2024.08.052.
• Results Manceau H, Ausseil J, Masson D, Feugeas JP, Sablonniere B, Guieu R, Puy H, Peoc'h K. Neglected Comorbidity of Chronic Heart Failure: Iron Deficiency. Nutrients. 2022 Aug 5;14(15):3214. doi: 10.3390/nu14153214.
• Results Zhou X, Xu W, Xu Y, Qian Z. Iron Supplementation Improves Cardiovascular Outcomes in Patients with Heart Failure. Am J Med. 2019 Aug;132(8):955-963. doi: 10.1016/j.amjmed.2019.02.018. Epub 2019 Mar 7.
• Results Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

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