IRONMAN Trial
Effectiveness of Intravenous Iron Treatment Versus Standard Care in Patients With Heart Failure and Iron Deficiency
A randomized, open-label, blinded-endpoint trial
Objective:
To evaluate the safety and efficacy of ferric derisomaltose on cardiovascular outcomes among patients with heart failure and iron deficiency.
1137 Patients
Inclusion Criteria:
- Age ≥18 years
- LVEF ≤45% within the last 2 years
- NYHA class II–IV
- Transferrin saturation ≤20% or ferritin <100 µg/L
- Increased risk of cardiovascular events and N-terminal pro BNP >250 ng/L if sinus rhythm or >1,000 ng/L if atrial fibrillation
Exclusion Criteria:
- Hb <9.0 g/dL
- Ferritin >400 µg/L
- GFR <15 mL/min/1.73 m²
Groups
- Ferric Derisomaltose:
- n = 569
- Usual Care:
- n = 568
Outcomes
Primary Outcome:
- Cardiovascular death or HF hospitalization (events/100 patient-years)
- Ferric Derisomaltose: 22.4 events
- Usual Care: 27.5 events
- Relative Risk (RR): 0.76
- 95% CI: 0.58-1.00
- P = 0.07
Secondary Outcomes:
- HF hospitalization (events/100 patient-years):
- Ferric Derisomaltose: 16.7 events
- Usual Care: 20.9 events
- P = 0.085
- Cardiovascular death (%):
- Ferric Derisomaltose: 21%
- Usual Care: 24%
- P = 0.23
- All-cause mortality (%):
- Ferric Derisomaltose: 32%
- Usual Care: 34%
- P = 0.64
Conclusion:
The results of this trial show that iron infusion is not superior to usual care among patients with HF and iron deficiency.
Source: