Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial
In: ISSN: 0140-6736, 2020
academicJournal
Zugriff:
International audience ; BackgroundIntravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure.MethodsAFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%), and had a left ventricular ejection fraction of less than 50%. Before hospital discharge, participants were randomly assigned (1:1) to receive intravenous ferric carboxymaltose or placebo for up to 24 weeks, dosed according to the extent of iron deficiency. To maintain masking of patients and study personnel, treatments were administered in black syringes by personnel not involved in any study assessments. The primary outcome was a composite of total hospitalisations for heart failure and cardiovascular death up to 52 weeks after randomisation, analysed in all patients who received at least one dose of study treatment and had at least one post-randomisation data point. Secondary outcomes were the composite of total cardiovascular hospitalisations and cardiovascular death; cardiovascular death; total heart failure hospitalisations; time to first heart failure hospitalisation or cardiovascular death; and days lost due to heart failure hospitalisations or cardiovascular death, all evaluated up to 52 weeks after randomisation. Safety was assessed in all patients for whom study treatment was started. A pre-COVID-19 sensitivity analysis on the primary and secondary outcomes was prespecified. This study is registered with ClinicalTrials.gov, NCT02937454, and has now been completed.FindingsBetween March 21, 2017, and July 30, 2019, 1525 patients ...
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Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial
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| Autor/in / Beteiligte Person: | Ponikowski, Piotr ; Kirwan, Bridget-Anne ; Anker, Stefan ; Mcdonagh, Theresa ; Dorobantu, Maria ; Drozdz, Jarosław ; Fabien, Vincent ; Filippatos, Gerasimos ; Göhring, Udo Michael ; Keren, Andre ; Khintibidze, Irakli ; Kragten, Hans ; Martinez, Felipe ; Metra, Marco ; Milicic, Davor ; Nicolau, José ; Ohlsson, Marcus ; Parkhomenko, Alexander ; Pascual-Figal, Domingo ; Ruschitzka, Frank ; Sim, David ; Skouri, Hadi ; van der Meer, Peter ; Lewis, Basil ; Comin-Colet, Josep ; von Haehling, Stephan ; Cohen-Solal, Alain ; Danchin, Nicolas ; Doehner, Wolfram ; Dargie, Henry ; Motro, Michael ; Butler, Javed ; Friede, Tim ; Jensen, Klaus ; Pocock, Stuart ; Jankowska, Ewa ; Wrocław Medical University ; London School of Hygiene and Tropical Medicine (LSHTM) ; Charité - UniversitätsMedizin = Charité - University Hospital Berlin ; King's College Hospital (KCH) ; Universitatea din Bucuresti (UB) ; University of Lódź = Uniwersytet Łódzki ; Vifor Pharma Ltd Glattbrugg, Switzerland ; National and Kapodistrian University of Athens (NKUA) ; Hadassah Hebrew University Medical Center Jerusalem ; Tbilisi State University ; Maastricht University Medical Centre (MUMC) ; Maastricht University Maastricht ; Prague University of Economics and Business (VSE) ; Università degli Studi di Brescia = University of Brescia (UniBs) ; University of Zagreb ; Universidade de São Paulo = University of São Paulo (USP) ; Skane University Hospital Malmo ; Skane University Hospital 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) ; Saint Joseph Medical Center Beirut ; University Medical Center Groningen Groningen (UMCG) ; Clinical Cardiovascular Research Institute Haifa, Israel (2CRI) ; Bellvitge University Hospital Barcelona, Spain ; University Medical Center Göttingen (UMG) ; Biomarqueurs CArdioNeuroVASCulaires (BioCANVAS / U942) ; Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; 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) ; Charité Campus Virchow-Klinikum (CVK) ; University of Glasgow ; Tel Aviv University (TAU) ; University of Southern Mississippi (USM) ; Socar Research S.A. Nyon, Switzerland (SR) ; AFFIRM-AHF investigators: G Azize, A Fernandez, G O Zapata, P Garcia Pacho, A Glenny, F Ferre Pacora, M L Parody, J Bono, C Beltrano, A Hershson, N Vita, H A Luquez, H G Cestari, H Fernandez, A Prado, M Berli, R García Durán, J Thierer, M Diez, L Lobo Marquez, R R Borelli, M Á Hominal, M Metra, P Ameri, P Agostoni, A Salvioni, L Fattore, E Gronda, S Ghio, F Turrini, M Uguccioni, M Di Biase, M Piepoli, S Savonitto, A Mortara, P Terrosu, A Fucili, G Boriani, P Midi, E Passamonti, F Cosmi, P van der Meer, P Van Bergen, M van de Wetering, Nyy Al-Windy, W Tanis, M Meijs, Rgej Groutars, Hks The, B Kietselaer, Ham van Kesteren, Dpw Beelen, J Heymeriks, R Van de Wal, J Schaap, M Emans, P Westendorp, P R Nierop, R Nijmeijer, O C Manintveld, M Dorobantu, D A Darabantiu, D Zdrenghea, D M Toader, L Petrescu, C Militaru, D Crisu, M C Tomescu, G Stanciulescu, A Rodica Dan, L C Iosipescu, D L Serban, J Drozdz, J Szachniewicz, M Bronisz, A Tycińska, B Wozakowska-Kaplon, E Mirek-Bryniarska, M Gruchała, J Nessler, E Straburzyńska-Migaj, K Mizia-Stec, R Szelemej, R Gil, M Gąsior, I Gotsman, M Halabi, M Shochat, M Shechter, V Witzling, R Zukermann, Y Arbel, M Flugelman, T Ben-Gal, V Zvi, W Kinany, J M Weinstein, S Atar, S Goland, D Milicic, D Horvat, S Tušek, M Udovicic, K Šutalo, A Samodol, K Pesek, M Artuković, A Ružić, J Šikić, T McDonagh, J Trevelyan, Y-K Wong, D Gorog, R Ray, S Pettit, S Sharma, A Kabir, H Hamdan, L Tilling, L Baracioli, L Nigro Maia, O Dutra, G Reis, P Pimentel Filho, J F Saraiva, A Kormann, F R Dos Santos, L Bodanese, D Almeida, D Precoma, S Rassi, F Costa, S Kabbani, K Abdelbaki, C Abdallah, M S Arnaout, R Azar, S Chaaban, O Raed, G Kiwan, B Hassouna, A Bardaji, J Zamorano, S Del Prado, J R Gonzalez Juanatey, F I Ga Bosa Ojeda, M Gomez Bueno, B D Molina, D A Pascual Figal, D Sim, T J Yeo, S Y Loh, D Soon, M Ohlsson, J G Smith, S Gerward, I Khintibidze, Z Lominadze, G Chapidze, N Emukhvari, G Khabeishvili, V Chumburidze, K Paposhvili, T Shaburishvili, G Khabeishvili, O Parhomenko, I Kraiz, O Koval, V Zolotaikina, Y Malynovsky, I Vakaliuk, L Rudenko, V Tseluyko, M Stanislavchuk. |
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| Zeitschrift: | ISSN: 0140-6736, 2020 |
| Veröffentlichung: | HAL CCSD ; Elsevier, 2020 |
| Medientyp: | academicJournal |
| DOI: | 10.1016/S0140-6736(20)32339-4 |
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