Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure (FAIR-HF2-DZHK05) trial : baseline characteristics and comparison to other relevant clinical trials

Anker, Stefan D. (author), Lainščak, Mitja (author)

Aims: Prior randomized trials have reported conflicting evidence regarding the efficacy of intravenous (IV) iron in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency (ID). Methods and results: FAIR-HF2 is a double-blind, randomized, controlled trial evaluating the efficacy of IV ferric carboxymaltose in patients with HFrEF and ID. We report the baseline characteristics of enrolled patients and compare them with other major trials of IV iron in HFrEF (FAIR-HF, CONFIRM-HF, AFFIRM-AHF, IRONMAN, and HEART-FID). A total of 1105 patients were randomized between March 2017 and November 2023. Most patients were men (67%) and median age was 72 (interquartile range [IQR] 63-79) years. More than one-third had a heart failure hospitalization within the preceding 12 months (36%), and 53% were hospitalized at randomization. Common comorbidities included hypertension (79%), coronary artery disease (74%), dyslipidaemia (67%), and diabetes (46%). The median left ventricular ejection fraction was 58% (IQR 42-77) and mean estimated glomerular filtration rate was 58 (IQR 42-77) ml/min/1.73 m2. A total of 1064 (96%) patients were on renin-angiotensin system inhibitors (angiotensin receptor-neprilysin inhibitors [ARNI] 38%), 1016 (92%) on beta-blockers, and 779 (71%) on mineralocorticoid receptor antagonists; and 261 (24%) of patients were on sodium-glucose cotransporter 2 (SGLT2) inhibitors, which is much higher than prior trials. A higher proportion of patients had ischaemic HFrEF (78%) compared to preceding trials. The baseline median haemoglobin (g/dl) was 12.7 (IQR 11.8-13.4), median serum ferritin (μg/dl) was 63 (IQR 36-90), and median transferrin saturation (%) was 16.5 (IQR 11.8-22.9), resembling that of other trials. The mean 6-min walk distance at enrolment was 314 ± 118 m. Conclusion: The FAIR-HF2 trial represents a contemporary cohort of patients with baseline characteristics mostly similar to prior trial populations. Use of SGLT2 inhibitors and ARNI in FAIR-HF2 was higher than in prior trials.

• Language: English
• Keywords: clinical trial, heart failure, hospitalization, iron deficiency, transferrin saturation
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2025
• Number of pages: Str. 1436-1443
• Numbering: Vol. 27, iss. 8
• PID: 20.500.12556/RUL-181689
• UDC: 616.1
• ISSN on article: 1388-9842
• DOI: 10.1002/ejhf.3658
• COBISS.SI-ID: 252020995
• Publication date in RUL: 13.04.2026

Record is a part of a journal

• Title: European journal of heart failure
• Shortened title: Eur. j. heart fail.
• Publisher: Elsevier
• ISSN: 1388-9842
• COBISS.SI-ID: 1217301

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: klinično preskušanje, srčno popuščanje, hospitalizacija, pomanjkanje železa, nasičenost transferina