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
Year: 2025
Type: article
Abstract: 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. Clinical Trial Registration: ClinicalTrials.gov ID NCT03036462.
DOI: 10.1002/ejhf.3658
Authors: Stefan D. Anker, Tim Friede, Javed Butler, Khawaja M. Talha, Marius Placzek, Monika Diek, Anna Nosko, Adriane Stas, Stefan Kluge, Dominik Jarczak, Geraldine Deheer, Meike Rybczynski, Antoni Bayes-Genis, Frank Edelmann, Gerasimos Filippatos, Gerd Hasenfuß, Wilhelm Haverkamp, Mitja Lainscak, Ulf Landmesser, Iain C. Macdougall, Bela Merkely, Burkert M. Pieske, Fausto J. Pinto, Tienush Rassaf, Maurizio Volterrani, Stephan von Haehling, Markus S. Anker, Wolfram Doehner, Hüseyin Ince, Friedrich Koehler, Gianluigi Savarese, Ursula Rauch-Kröhnert, Tommaso Gori, Teresa Trenkwalder, Ibrahim Akin, Christina Paitazoglou, Iwona Kobielusz-Gembala, Witold Zmuda, Luca Kuthi, Norbert Frey, Manuela Licka, Stefan Kääb, Karl-Ludwig Laugwitz, Piotr Ponikowski, Mahir Karakas
Institutions: Deutsches Herzzentrum der Charité, Berlin-Brandenburger Centrum für Regenerative Therapien, German Centre for Cardiovascular Research, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Charité - Universitätsmedizin Berlin, Universitätsmedizin Göttingen, University of Göttingen, University of Mississippi Medical Center, Baylor Scott & White Research Institute, Loyola University Medical Center, Loyola Medicine, University Medical Center Hamburg-Eppendorf, Centro de Investigación en Red en Enfermedades Cardiovasculares, Hospital Universitari Germans Trias i Pujol, National and Kapodistrian University of Athens, University of Ljubljana, King's College Hospital, Semmelweis University, Universitätsmedizin Rostock, University of Rostock, University of Lisbon, Centro Académico de Medicina de Lisboa, Essen University Hospital, West German Heart and Vascular Center Essen, University of Duisburg-Essen, San Raffaele University of Rome, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, University of Glasgow, Karolinska Institutet, Humboldt-Universität zu Berlin, Stockholm South General Hospital, Freie Universität Berlin, University Medical Center of the Johannes Gutenberg University Mainz, Deutsches Herzzentrum München, Technical University of Munich, Heidelberg University, University Medical Centre Mannheim, Medizinische Fakultät Mannheim, University Hospital Schleswig-Holstein, University of Lübeck, University Hospital Heidelberg, LMU Klinikum, Ludwig-Maximilians-Universität München, TUM Klinikum, University of Wrocław, Wroclaw Medical University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,300
OpenAlex ID: W4409912038