IRONOUT-HF
Trial question
What is the effect of oral iron repletion on exercise capacity in patients with HFrEF and iron deficiency?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 225
225 patients (80 female, 145 male).
Inclusion criteria: patients with HF with reduced LVEF < 40% and iron deficiency.
Key exclusion criteria: presence of neuromuscular, orthopedic or other noncardiac condition preventing patient from exercise testing, severe renal dysfunction, severe liver disease, IBD, known active infection, active gastrointestinal bleeding, active malignancy, iron overload disorders.
Interventions
N=111 oral iron polysaccharide (150 mg BID for 16 weeks).
N=114 placebo (matched placebo BID for 16 weeks).
Primary outcome
Change in peak oxygen uptake at 16 weeks
23 mL/min
-2 mL/min
23.0 mL/min
17.3 mL/min
11.5 mL/min
5.8 mL/min
0.0 mL/min
-5.8 mL/min
Oral iron
polysaccharide
Placebo
No significant
difference ↔
No significant difference in change in peak oxygen uptake at 16 weeks (23 mL/min vs. -2 mL/min; difference 21, 95% CI -34 to 76).
Conclusion
In patients with HF with reduced LVEF < 40% and iron deficiency, oral iron polysaccharide was not superior to placebo with respect to change in peak oxygen uptake at 16 weeks.
Reference
Lewis GD, Malhotra R, Hernandez AF et al. Effect of Oral Iron Repletion on Exercise Capacity in Patients With Heart Failure With Reduced Ejection Fraction and Iron Deficiency: The IRONOUT HF Randomized Clinical Trial. JAMA. 2017 May 16;317(19):1958-1966.
Open reference URL