About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Hemoglobin <9.0 g/dL or Hemoglobin >15.0 g/dL.
Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2.
Body weight <35 kg.
Heart failure was secondary to valvular diseases or congenital heart diseases.
Trial design
Treatments tested in this trial
- High-dose ferric derisomaltose
- Low-dose ferric derisomaltose