The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)
This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.
⁃ Age \>18 years.
⁃ Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).
⁃ New York Heart Association (NYHA) class II \
• III.
⁃ Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \>300 pg/mL or BNP \>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP \>600 pg/mL or BNP \>200 pg/mL.
⁃ Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).
⁃ Serum ferritin \<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \<20%.
⁃ Able and willing to perform a CPET at the time of randomization.
⁃ Able and willing to provide informed consent.