{"id":"1f0932779c5c","type":"article","url":"https://hartvaat.nl/2023/09/14/heart-fid-iv-ferricarboxymaltose-bij-hartfalen-met-ijzerdeficientie-nejm/","title":"HEART-FID: IV ferricarboxymaltose bij hartfalen met ijzerdeficiëntie — NEJM","title_en":"Ferric Carboxymaltose in Heart Failure with Iron Deficiency.","category":"hartfalen","category_label":"Hartfalen","professions":["apotheker","cardioloog","internist"],"tags":["acuut-hartfalen","dapa-hf","iaso-dcm","ijzersuppletie","ijzertekort","step-hfpef"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa2304968","source_url":"https://doi.org/10.1056/NEJMoa2304968","authors":["Robert J Mentz","Jyotsna Garg","Frank W Rockhold","Javed Butler","Carmine G De Pasquale","Justin A Ezekowitz","Gregory D Lewis","Eileen O'Meara","Piotr Ponikowski","Richard W Troughton","Yee Weng Wong","Lilin She","Josephine Harrington","Robert Adamczyk","Nicole Blackman","Adrian F Hernandez"],"significance":9,"published":"2023-09-14","source_date":"2023-09-14","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/digoxine-bij-hartfalen/"],"congress":"","summary_en":"The HEART-FID trial showed that intravenous ferric carboxymaltose in patients with HFrEF and iron deficiency did not significantly improve the hierarchical composite of death, heart failure hospitalization, and 6-minute walk distance. The neutral result contrasted with positive findings from AFFIRM-AHF and IRONMAN.","created":"2026-07-03T10:30:34Z","updated":"2026-07-03T18:39:06Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"De HEART-FID-trial in de NEJM toonde dat IV ferricarboxymaltose bij HFrEF met ijzerdeficiëntie het gecombineerde primaire eindpunt (sterfte, HF-hospitalisatie, 6-minutenlooptest) net niet significant verbeterde. De individuele componenten toonden gunstige trends.","abstract_original":"BACKGROUND: Ferric carboxymaltose therapy reduces symptoms and improves quality of life in patients who have heart failure with a reduced ejection fraction and iron deficiency. Additional evidence about the effects of ferric carboxymaltose on clinical events is needed. METHODS: In this double-blind, randomized trial, we assigned ambulatory patients with heart failure, a left ventricular ejection fraction of 40% or less, and iron deficiency, in a 1:1 ratio, to receive intravenous ferric carboxymaltose or placebo, in addition to standard therapy for heart failure. Ferric carboxymaltose or placebo was given every 6 months as needed on the basis of iron indexes and hemoglobin levels. The primary outcome was a hierarchical composite of death within 12 months after randomization, hospitalizations for heart failure within 12 months after randomization, or change from baseline to 6 months in the 6-minute walk distance. The significance level was set at 0.01. RESULTS: We enrolled 3065 patients, of whom 1532 were randomly assigned to the ferric carboxymaltose group and 1533 to the placebo group. Death by month 12 occurred in 131 patients (8.6%) in the ferric carboxymaltose group and 158 (10.3%) in the placebo group; a total of 297 and 332 hospitalizations for heart failure, respectively, occurred by month 12; and the mean (±SD) change from baseline to 6 months in the 6-minute walk distance was 8±60 and 4±59 m, respectively (Wilcoxon-Mann-Whitney P = 0.02; unmatched win ratio, 1.10; 99% confidence interval, 0.99 to 1.23). Repeated dosing of ferric carboxymaltose appeared to be safe with an acceptable adverse-event profile in the majority of patients. The number of patients with serious adverse events occurring during the treatment period was similar in the two groups (413 patients [27.0%] in the ferric carboxymaltose group and 401 [26.2%] in the placebo group). CONCLUSIONS: Among ambulatory patients who had heart failure with a reduced ejection fraction and iron deficiency, there was no apparent difference between ferric carboxymaltose and placebo with respect to the hierarchical composite of death, hospitalizations for heart failure, or 6-minute walk distance. (Funded by American Regent, a Daiichi Sankyo Group company; HEART-FID ClinicalTrials.gov number, NCT03037931.)."}