Rationale and Design of a Prospective, Multicenter, Observational Study Evaluating Iron Deficiency in Patients Hospitalized for Heart Failure (FERIC-RO)

Abstract

Introduction: Several landmark studies, which enrolled heart failure (HF) patients who were ambulatory at the time of inclusion, identified iron deficiency (ID) as an important therapeutic target: intravenous iron administration with ferric carboxymaltose (FCM) improves morbidity, exercise capacity, and quality of life in patients with HF and reduced EF (HFrEF). However, there is still limited knowledge about ID prevalence during hospitalization for Worsening Chronic HF (WCHF) and about the relationship between ID during hospitalization and post-discharge outcomes. Although previous studies documented ID as an independent risk factor for poor outcomes in HFrEF, its prognostic significance in HF patients with EF>40% remains unclear. Method and Results: The FERIC-RO study is a prospective, multicenter, observational study with longitudinal follow up, conducted in 9 Romanian hospitals that will include 200 consecutive patients admitted for worsening HF. A comprehensive description of the Iron metabolism biomarkers will be performed on discharge and 1-month follow up. The primary endpoint is defined as the prevalence of ID on discharge and 1-month post-discharge, and the secondary endpoints include: all-cause re-hospitalization and all-cause-mortality at 1 and 3 months follow up, and quality of life on discharge and 1-month. Conclusions: FERIC-RO will provide new evidence about the prevalence and the predictors of ID in patients hospitalized for WCHF regardless of LVEF. Furthermore, the study will explore the relationship between in-hospital ID and post-discharge outcomes. The results of FERIC-RO will thus be highly relevant to the management of patients hospitalized for AHF.