A phase III, randomized, open-label, blinded endpoint, comparative trial of ferric derisomaltose versus no intravenous iron in iron-deficient subjects with symptomatic chronic heart failure

Chronic Heart Failure

Primary efficacy endpoint: Number of cardiovascular deaths and hospitalizations for worsening heart failure

Key Secondary efficacy endpoints: • Time to first hospitalization for worsening heart failure or cardiovascular death, Key Secondary efficacy endpoints: • Number of hospitalizations for worsening heart failure, Key Secondary efficacy endpoints: • Number of all-cause hospitalizations, Key Secondary efficacy endpoints: • Time to cardiovascular death, Key Secondary efficacy endpoints: • Time to all-cause death, Secondary efficacy endpoints: • Number of hospitalizations for cardiovascular, respiratory, or renal disease, Secondary efficacy endpoints: • Time to cardiovascular, respiratory, or renal death, Secondary efficacy endpoints: • Number of hospitalizations for cardiovascular events: stroke, acute myocardial infarct (AMI), and heart failure, Secondary efficacy endpoints: • Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI, and heart failure, Secondary efficacy endpoints: • Time to all-cause death or first hospitalization, Secondary efficacy endpoints: • Days hospitalized or dead for cardiovascular reasons at week 52, Secondary efficacy endpoints: • Days hospitalized or dead for any reason at week 52, Secondary efficacy endpoints: • Change in New York Heart Association (NYHA) from baseline to weeks 12, 26, and 52, Secondary efficacy endpoints: • All-cause rehospitalizations at 30 and 60 days, Secondary efficacy endpoints: • Rehospitalizations for worsening heart failure at 30 and 60 days, Secondary efficacy endpoints: • Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment, Secondary efficacy endpoints: • Number of urgent and unscheduled outpatient IV diuretic treatment, PD endpoint: Change in Hb, s-ferritin, TSAT, s-iron, and TIBC from baseline to weeks 26 and 52, Safety endpoints: • Type and incidence of serious adverse events (SAEs), Safety endpoints: • In addition, vital signs and safety laboratory parameters will be measured as part of standard safety assessments.

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