Marco Metra, Marcus Andreas Ohlsson, Basil S. Lewis, Wolfram Doehner, Peter van der Meer, Irakli Khintibidze, Hans Kragten, Bridget-Anne Kirwan, Jose C. Nicolau, Vincent Fabien, Tim Friede, Nicolas Danchin, Ewa A. Jankowska, Gerasimos Filippatos, Alain Cohen-Solal, Fabio Dorigotti, Hadi Skouri, Davor Miličić, Andre Keren, Alexander Parkhomenko, Jarosław Drożdż, David Sim, Stuart J. Pocock, Michael Motro, Javed Butler, Domingo A. Pascual-Figal, Theresa McDonagh, Henry J. Dargie, Josep Comín-Colet, Maria Dorobantu, Mikhail Kosiborod, Frank Ruschitzka, Stephan von Haehling, Piotr Ponikowski, Stefan D. Anker, Felipe Martinez, Cardiovascular Centre (CVC), Restoring Organ Function by Means of Regenerative Medicine (REGENERATE), leboeuf, Christophe, Wrocław Medical University, Socar Research S.A. [Nyon, Switzerland] (SR), London School of Hygiene and Tropical Medicine (LSHTM), Saint Luke's Mid America Heart Institute, University of Missouri [Kansas City] (UMKC), University of Missouri System, University of Mississippi Medical Center (UMMC), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], King‘s College London, Universitatea din Bucuresti (UB), Medical University of Łódź (MUL), National and Kapodistrian University of Athens (NKUA), Université d'Athènes (UOA), Assuta Hospital in Ramat HaHayal [Tel Aviv-Yafo, Israel] (AHRH), Tbilisi State University, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], Prague University of Economics and Business, Università degli Studi di Brescia = University of Brescia (UniBs), Civic Hospital of Brescia, University of Zagreb, Skane University Hospital [Malmo], Lund University [Lund], National Scientific Center 'M.D. Strazhesko Institute of Cardiology' [Kyiv, Ukraine] (NSC/MDSIC), Universidad de Murcia, University hospital of Zurich [Zurich], National Heart Centre Singapore (NHCS), American University of Beirut Faculty of Medicine and Medical Center (AUB), University Medical Center Groningen [Groningen] (UMCG), Rappaport faculty of Medicine, Technion - Israel Institute of Technology [Haifa], L’Hospitalet de Llobregat [Barcelona, Spain], Institut d'Investigació Biomèdica de Bellvitge [Barcelone] (IDIBELL), University Medical Center Göttingen (UMG), German Center for Cardiovascular Research (DZHK), Berlin Institute of Health (BIH), Marqueurs cardiovasculaires en situation de stress (MASCOT (UMR_S_942 / U942)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), University of Glasgow, Tel Aviv University (TAU), Kfar Saba and Sackler School of Medicine, Vifor Pharma Ltd [Glattbrugg, Switzerland], and University College of London [London] (UCL)
Aims Patients with heart failure (HF) and iron deficiency experience poor health-related quality of life (HRQoL). We evaluated the impact of intravenous (IV) ferric carboxymaltose (FCM) vs. placebo on HRQoL for the AFFIRM-AHF population. Methods and results The baseline 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12), which was completed for 1058 (535 and 523) patients in the FCM and placebo groups, respectively, was administered prior to randomization and at Weeks 2, 4, 6, 12, 24, 36, and 52. The baseline KCCQ-12 overall summary score (OSS) mean ± standard error was 38.7 ± 0.9 (FCM group) and 37.1 ± 0.8 (placebo group); corresponding values for the clinical summary score (CSS) were 40.9 ± 0.9 and 40.1 ± 0.9. At Week 2, changes in OSS and CSS were similar for FCM and placebo. From Week 4 to Week 24, patients assigned to FCM had significantly greater improvements in OSS and CSS scores vs. placebo [adjusted mean difference (95% confidence interval, CI) at Week 4: 2.9 (0.5–5.3, P = 0.018) for OSS and 2.8 (0.3–5.3, P = 0.029) for CSS; adjusted mean difference (95% CI) at Week 24: 3.0 (0.3–5.6, P = 0.028) for OSS and 2.9 (0.2–5.6, P = 0.035) for CSS]. At Week 52, the treatment effect had attenuated but remained in favour of FCM. Conclusion In iron-deficient patients with HF and left ventricular ejection fraction, Graphical Abstract