Drug: Placebos / Normal Saline Solution
This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) for patients in heart failure with iron deficiency. After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels overtime in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.
1. known hypersensitivity reaction to any component of fcm.
2. history of acquired iron overload, or the recent receipt (within 3 months) of
erythropoietin stimulating agent, iv iron therapy, or blood transfusion.
3. acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or
stroke within 30 days of enrollment.
4. uncorrected severe aortic stenosis, severe valvular regurgitation, or left ventricular
outflow obstruction requiring intervention.
5. current atrial fibrillation or atrial flutter with a mean ventricular response rate
>100 per minute (at rest).
6. current or planned mechanical circulatory support or heart transplantation.
7. hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
8. documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate
transaminase >3 times the upper limit of normal range).
9. current or recent (within 3 years) malignancy with exception of basal cell carcinoma
or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
10. active gastrointestinal bleeding.
11. female participant of child-bearing potential who is pregnant, lactating, or not
willing to use adequate contraceptive precautions during the study and for up to 5
days after the last scheduled dose of study medication.
12. inability to return for follow up visits within the necessary windows
13. concurrently in a study with investigational product.
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