The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Pa… (NCT06427343) | Clinical Trial Compass
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
China114 participantsStarted 2023-10-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Hemoglobin \<9.0 g/dL or Hemoglobin \>15.0 g/dL.
. Heart failure was secondary to valvular diseases or congenital heart diseases.
✕. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.
✕. Known hypersensitivity to ferric derisomaltose or other IV iron product.
✕. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.
✕. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV/AIDS disease.