The effect of intravenous ferric carboxymaltose on health-related quality of life in iron-deficient patients with acute heart failure: the results of the AFFIRM-AHF study

Department of Heart Diseases, Wrocław Medical University, Borowska 213, 50-556 Wroclaw, Poland. Center for Heart Diseases, University Hospital in Wrocław, Borowska 213, 50-556 Wroclaw, Poland. Department of Clinical Research, SOCAR Research SA, Chemin de Chantemerle 18, 1260 Nyon, Switzerland. London School of Hygiene and Tropical Medicine, University College London, Keppel St, Bloomsbury, London WC1E 7HT, UK. Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, 4401 Wornhall Rd, Kansas City, MO 64111, USA. University of Mississippi Medical Center, 2500 North State Street, Jackson, MS 39216, USA. Charité, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany. King's College Hospital, Denmark Hill, Brixton, London SE5 9RS, UK. King's College London, Strand, London WC2R 2LS, UK. Cardiology Department, Emergency Hospital of Bucharest, Calea Floreasca 8, Bucharest 014461, Romania. Department Cardiology, Medical University of Lodz, al. Tadeusza Kościuszki 4, 90-149 Lodz, Poland. Department of Cardiology, Heart Failure Unit, National and Kapodistrian University of Athens, School of Medicine, Athens University Hospital Attiko, Athens 157 72, Greece. Assuta Hashalom, Assuta Hospitals, HaBarzel St 20, Tel Aviv-Yafo, Israel. Aleksandre Aladashvili Clinic, LLC, 103 Uznadze St., Tbilisi, Georgia. Maastricht University Medical Center, P. Debyelaan 25, 6229 Maastricht, Netherlands. Universidad Nacional de Córdoba, International Society of Cardiovascular Pharmacotherapy, Av. Haya de la Torre s/n, Argentina. Department of Cardiology, University and Civil Hospital, Piazzale Spedali Civilli, 1, 25123 Brescia, Italy. University Hospital Center Zagreb, Kišpatićeva ul. 12, 10000 Zagreb, Croatia. Instituto do Coracao (InCor), Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Av. Dr. Enéas Carvalho de Aguiar, 44 - Cerqueira César, Sao Paulo-SP, 05403-900, Brazil. Department of Internal Medicine, Skane University Hospital Malmo, Carl-Bertil Laurells gata 9, 214 28 Malmo, Sweden. The M.D. Strazhesko Institute of Cardiology, Narodnoho Opolchennya St, 5, Kyiv 03680, Ukraine. Cardiology Department, Hospital Virgen de la Arrixaca, University of Murcia, Ctra. Madrid-Cartagena, s/n, 30120 El Palmar, Murcia, Spain. UniversitätsSpietal Zürich, Klinik für Kardiologie, Rämistrasse 100, 8006 Zürich, Switzerland. National Heart Center, Clinical Translational and Research Office, 5 Hospital Dr, Singapore 169609. American University of Beirut, Medical Center Beirut, Maamari Street - Hamra, 1107 2020 Beirut, Lebanon. Department of Cardiology, University Medical Center Groningen, Hanzeplein 1, 9713 Groningen, The Netherlands. Lady Davies Carmel Medical Center, Clinical Cardiovascular Research Institute, 21 Ehud Street, Haifa, Haifa District, Israel. Department of Cardiology, University Hospital Bellvitge and IDIBELL, University of Barcelona, Gran Via de l'Hospitalet, 199 08908, Hospitalet de Llobregat, Barcelona, Spain. Department of Cardiology and Pneumology, University Medical Center Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany. German Center for Cardiovascular Research (DZHK), partner site Göttingen, 37099 Göttingen, Germany. Hospital Lariboisière, INSERM, 2 Rue Ambroise Paré, 75010 Paris, France. European Hospital Georges Pompidou, 20 Rue Leblanc, 75015 Paris, France. BCRT-Berlin Institute of Health Center for Regenerative Therapies, Föhrer Str. 15, 13353; Department of Cardiology (Virchow Campus), Charité- Universitätsmedizin Berlin, Augustenburger Pl. 1, 13353; and German Centre for Cardiovascular Research (DZHK), Partner Site Berlin, Potsdamer Straße 58, 10785 Berlin, Germany. Robertson Center for Biostatistics, University of Glasgow, Boyd Orr Building University Avenue, Glasgow G12 8QQ, UK. Sheba Medical Center, Tel-Aviv University, Sackler School of Medicine, 6997801 Tel Aviv, Israel. Department of Medical Statistics, University Medical Center Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany. Vifor Pharma Ltd, Flughofstrasse 61, P.O. Box 8152, Glattbrugg, Switzerland.

European heart journal. 2021
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 ≤50% who had stabilized after an episode of acute HF, treatment with IV FCM, compared with placebo, results in clinically meaningful beneficial effects on HRQoL as early as 4 weeks after treatment initiation, lasting up to Week 24.
Study details
Language : eng
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