Intravenous iron may benefit patients with chronic heart failure: IRONMAN Trial.
IRONMAN trial found that in heart failure patients with reduced left ventricular ejection fraction and iron deficiency, intravenous ferric derisomaltose administration was associated with a reduced risk of hospital admissions and cardiovascular death. The trial results were published in The Lancet journal.
Iron deficiency is common in patients with chronic heart failure, despite the left ventricular ejection fraction or hemoglobin concentrations. It is independently associated with severe symptoms, poorer exercise capacity, and an increased risk of hospitalization and death. Intravenous ferric carboxymaltose administration in patients with heart failure having reduced left ventricular ejection fraction and iron deficiency, has given short-term benefits of improving the quality of life, and exercise capacity and also reduces hospital admissions for heart failure up to 1 year. Hence researchers conducted a prospective, randomized, open-label, blinded-endpoint trial aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure.
IRONMAN trial was carried out at 70 hospitals in the UK. Eligible patients aged 18 years or older with heart failure and having a left ventricular ejection fraction ≤45% and transferrin saturation of less than 20% or serum ferritin less than 100 μg/L were enrolled in the study. By using a web-based system, participants were randomly assigned (1:1) to intravenous ferric derisomaltose or usual care, stratified by recruitment context and trial site. Based on the patient's body weight and hemoglobin concentration, the intravenous ferric derisomaltose dose was calculated. The primary outcome was recurrent hospital admissions for heart failure and cardiovascular death, assessed in all validly randomly assigned patients. Safety was assessed in all patients assigned to ferric derisomaltose who received at least one infusion and all patients assigned to usual care. A COVID-19 sensitivity analysis censoring follow-up on Sept 30, 2020, was prespecified.
Trial results:
- Out of 1869 patients screened, 1137 eligible patients were randomly assigned to receive intravenous ferric derisomaltose (n=569) or usual care (n=568).
- Median follow-up was 2·7 years (IQR 1·8–3·6).
- The ferric derisomaltose group had 336 primary endpoints (22·4 per 100 patient-years) and the usual care group had 411 (27·5 per 100 patient-years).
- There were 210 primary endpoints (22·3 per 100 patient-years) in the ferric derisomaltose group compared with 280 (29·3 per 100 patient-years) in the usual care group (RR 0·76 [95% CI 0·58 to 1·00]; p=0·047) as per the COVID-19 analysis.
- There were no between-group differences in deaths or hospitalizations due to infections.
- Fewer patients in the ferric derisomaltose group had cardiac serious adverse events (200) than in the usual care group (243; difference 7·00%).
Thus, intravenous ferric derisomaltose administration can reduce the risk of hospital admissions for heart failure and cardiovascular death in patients with heart failure who have reduced left ventricular ejection fraction and iron deficiency.
