1. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design
- Author
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Richard W. Troughton, Marc D. Samsky, Frank W. Rockhold, Robert J. Mentz, Dianne Leloudis, Linda M. Mundy, Adrian F. Hernandez, Justin A. Ezekowitz, Carmine G. De Pasquale, Michael Dugan, Eileen O'Meara, Andrew P. Ambrosy, Jyostna Garg, Yee Weng Wong, Javed Butler, and Gregory D. Lewis
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Methods Paper ,Placebo-controlled study ,heart failure ,intravenous iron therapy ,Gastroenterology ,Ferric Compounds ,FERRIC CARBOXYMALTOSE ,Ventricular Dysfunction, Left ,iron deficiency ,Internal medicine ,Medicine ,Humans ,transferrin ,Maltose ,Aged ,Ejection fraction ,Anemia, Iron-Deficiency ,business.industry ,ferritin ,Editorials ,Stroke Volume ,Iron deficiency ,Middle Aged ,hemoglobin ,medicine.disease ,Treatment Outcome ,Editorial ,Heart failure ,Ferritins ,Female ,Cardiology and Cardiovascular Medicine ,business - 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 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.
- Published
- 2021