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Amongst iron-deficient sufferers with coronary heart failure with lowered ejection fraction (HFrEF), receiving intravenous iron supplementation was discovered to be secure however resulted in combined findings, in keeping with a examine offered on the American Faculty of Cardiology’s Annual Scientific Session (ACC.25).
The outcomes of the FAIR-HF2 trial have been concurrently printed within the JAMA and the meta-analysis was concurrently printed on-line in Nature Drugs on the time of presentation.
Regardless of falling quick on the first endpoints associated to cardiovascular occasions, the findings indicated that the time to first cardiovascular loss of life or coronary heart failure hospitalization was about 20% decrease in these receiving intravenous iron. The outcomes additionally confirmed different indicators of lowered cardiovascular occasion charges within the first 12 months of iron supplementation when the dosage was highest, together with enhancements in secondary endpoints associated to high quality of life.
The trial’s findings have been additionally included in a meta-analysis that confirmed a big good thing about intravenous iron supplementation in a complete of over 7,000 sufferers with HFrEF throughout a number of scientific trials.
“If we take the totality of evidence from this new trial, which is in line with the previous studies, and take all of the data together in a meta-analysis, it confirms what we have in the current guidelines, namely, that intravenous iron for patients with HFrEF is useful,” stated Stefan D. Anker, MD, a coronary heart failure heart specialist at Charité–Universitätsmedizin Berlin in Germany and the examine’s first creator.
“It has a positive effect on symptoms and quality of life—you feel better, and you function better—and you also get an added bonus in terms of reducing cardiovascular events and heart failure hospitalizations, particularly in the first year after the start of the treatment.”
HFrEF happens when the center turns into too weak to successfully pump blood all through the physique. Iron deficiency, or having a lower-than-normal quantity of iron within the blood, is extra widespread in individuals with coronary heart failure than within the common inhabitants, and it’s related to worse coronary heart failure outcomes along with signs corresponding to fatigue, weak spot and shortness of breath. Screening for iron deficiency is really useful for the remedy and administration of sufferers with coronary heart failure.
The trial, referred to as FAIR-HF2, enrolled 1,105 sufferers with HFrEF at 70 facilities in six nations (Germany, Italy, Portugal, Slovenia, Hungary and Poland) All sufferers had iron deficiency at baseline, outlined as a blood ferritin degree of lower than 100 ng/mL or a blood ferritin degree of 100–299 ng/mL with transferrin saturation (TSAT) of lower than 20%, one other measure of iron ranges primarily based on the quantity of iron that’s sure to the protein transferrin.
About two-thirds of the members have been males and their median age was 70 years. Most sufferers have been taking commonplace coronary heart failure medicines and plenty of additionally had cardiovascular danger elements and comorbidities corresponding to hypertension, diabetes or coronary artery illness.
Half of the examine members have been randomly assigned to obtain intravenous iron supplementation and half obtained intravenous saline; sufferers have been blinded to their assigned routine. Sufferers randomized to iron supplementation obtained an preliminary dose of 1,000 mg–2,000 mg of ferric carboxymaltose (an iron preparation given intravenously), with the quantity and timing depending on physique weight and baseline hemoglobin.
In line with the outcomes, sufferers within the remedy group had a 21% decrease danger of cardiovascular loss of life or first coronary heart failure hospitalization total; nonetheless, the between-group distinction didn’t meet the brink for statistical significance for this main endpoint.
The 2 different main endpoints—the overall fee of coronary heart failure hospitalization (together with each first hospitalization and readmissions) and the time to first occasion of cardiovascular loss of life or coronary heart failure hospitalization among the many subgroup of sufferers with TSAT under 20% at baseline—additionally didn’t attain statistical significance regardless of nominal reductions of 20% and 21%, respectively, amongst these receiving intravenous iron supplementation.
Because the preliminary dose of iron supplementation was increased than subsequent doses, the typical complete iron obtained amongst these randomized to the remedy group was 2,040 mg within the first 12 months, 925 mg within the second 12 months and 750 mg within the third 12 months. Researchers stated that this variation within the quantity of iron obtained seemingly influenced the outcomes for the first endpoints, which confirmed bigger between-group variations at one 12 months in contrast with two-year and three-year timepoints.
“Intravenous iron was particularly useful in the first year, when the highest dose of iron was given. This suggests that there is a meaningful association between the amount of iron given and the benefit,” Anker stated.
The meta-analysis confirmed comparable patterns when it comes to the remedy results of intravenous iron within the first 12 months of remedy and steered that additional analysis might assist to elucidate the optimum technique for iron supplementation past the primary 12 months.
Sufferers receiving iron supplementation additionally reported vital high quality of life enhancements over these receiving saline, as assessed with questionnaires measuring health-related high quality of life and perceived well-being.
The outcomes confirmed no vital distinction between teams when it comes to security outcomes together with all-cause mortality, cardiovascular mortality or infections at three years.
“Based on the totality of evidence that is now available, we can with certainty say that intravenous iron therapy at the doses given in FAIR-HF2 and other recent trials is safe,” Anker stated.
The trial’s follow-up procedures and length have been negatively impacted by the COVID-19 pandemic, budgetary constraints and a change in worldwide coronary heart failure remedy pointers which led some sufferers to cease their assigned routine early. Because of this, researchers stated that the noticed variations between teams have been of a decrease magnitude than the examine was designed to evaluate, however nonetheless according to the general course of findings in earlier trials and meta-analyses.
Because the FAIR-HF2 trial solely included sufferers with HFrEF, Anker stated that extra analysis is required to find out whether or not intravenous iron supplementation additionally brings advantages for individuals with coronary heart failure with preserved ejection fraction, a special kind of coronary heart failure. As well as, primarily based on the outcomes of the meta-analysis, he stated that it will likely be necessary to higher perceive variations within the cardiovascular advantages of intravenous iron supplementation in girls versus males.
Extra data:
Stefan D. Anker et al, Systematic evaluation and meta-analysis of intravenous iron remedy for sufferers with coronary heart failure and iron deficiency, Nature Drugs (2025). DOI: 10.1038/s41591-025-03671-1
Stefan D. Anker et al, Intravenous Ferric Carboxymaltose in Coronary heart Failure With Iron Deficiency, JAMA (2025). DOI: 10.1001/jama.2025.3833
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Intravenous iron provides some advantages for some sufferers with coronary heart failure (2025, March 31)
retrieved 31 March 2025
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