Robert J Mentz1, Andrew P Ambrosy2,3, Justin A Ezekowitz4, Gregory D Lewis5, Javed Butler6, Yee Weng Wong7, Carmine G De Pasquale8, Richard W Troughton9, Eileen O'Meara10, Frank W Rockhold1, Jyostna Garg1, Marc D Samsky1, Dianne Leloudis1, Michael Dugan11, Linda M Mundy11, Adrian F Hernandez1. 1. Duke Clinical Research Institute, Durham, NC (R.J.M., F.R., J.G., M.D.S., D.L., A.F.H.). 2. Division of Cardiology, The Permanente Medical Group, San Francisco, CA (A.P.A.). 3. Division of Research, Kaiser Permanente Northern California, Oakland (A.P.A.). 4. Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (J.A.E.). 5. Division of Cardiology, Massachusetts General Hospital, Boston (G.D.L.). 6. Department of Medicine, University of Mississippi, Jackson (J.B.). 7. Heart Lung Institute, The Prince Charles Hospital, and School of Clinical Medicine, The University of Queensland, Australia (Y.W.W.). 8. Flinders Medical Centre, Adelaide, South Australia (C.G.D.P.). 9. Department of Medicine, Christchurch Heart Institute, University of Otago, Christchurch, New Zealand (R.W.T.). 10. Montreal Heart Institute and Université de Montréal, Quebec, Canada (E.O.). 11. American Regent, Inc, Norristown, Pennsylvania (M.D., L.M.M.).
Abstract
BACKGROUND: Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited. METHODS: The objective of the HEART-FID trial (Ferric Carboxymaltose in Heart Failure With Iron Deficiency) is to assess efficacy and safety of ferric carboxymaltose compared with placebo as treatment for symptomatic HF with reduced ejection fraction with ID. HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial enrolling ≈3014 patients at ≈300 international centers. Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide. Consented patients are assigned to ferric carboxymaltose or placebo at baseline, with repeated visits/assessments every 6 months for additional study drug based on hemoglobin and iron indices for the trial duration. The primary end point is a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance. CONCLUSIONS: The HEART-FID trial will inform clinical practice by clarifying the role of long-term treatment with intravenous ferric carboxymaltose, added to usual care, in ambulatory patients with symptomatic HF with reduced ejection fraction with ID. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037931.
RCT Entities:
BACKGROUND:Iron deficiency (ID) has a prevalence of ≈40% to 50% among patients in heart failure (HF) with reduced ejection fraction and is associated with worse prognosis. Several trials demonstrated that intravenous ferric carboxymaltose leads to early and sustained improvement in patient-reported outcomes and functional capacity in patients with HF with reduced ejection fraction with ID, yet morbidity and mortality data are limited. METHODS: The objective of the HEART-FID trial (Ferric Carboxymaltose in Heart Failure With Iron Deficiency) is to assess efficacy and safety of ferric carboxymaltose compared with placebo as treatment for symptomatic HF with reduced ejection fraction with ID. HEART-FID is a multicenter, randomized, double-blind, placebo-controlled trial enrolling ≈3014 patients at ≈300 international centers. Eligible patients are aged ≥18 years in stable chronic HF with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, ID (ferritin <100 ng/mL or ferritin 100-300 ng/mL with a transferrin saturation <20%), and documented HF hospitalization or elevated N-terminal pro-brain natriuretic peptide. Consented patients are assigned to ferric carboxymaltose or placebo at baseline, with repeated visits/assessments every 6 months for additional study drug based on hemoglobin and iron indices for the trial duration. The primary end point is a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance. CONCLUSIONS: The HEART-FID trial will inform clinical practice by clarifying the role of long-term treatment with intravenous ferric carboxymaltose, added to usual care, in ambulatory patients with symptomatic HF with reduced ejection fraction with ID. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037931.