Iron Deficiency Clinical Trial
Official title:
Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency: Effects Upon Phosphate and FGF23 Metabolism
Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study.
Iron deficiency is highly prevalent in patients with HFREF and intravenous high-dose (HD)
iron application has significantly improved clinically meaningful endpoints in such patients.
The best evidence is existent for ferric carboxymaltose. Intravenous HD iron may influence
phosphate metabolism via increases in levels of intact FGF23 and hence induce prolonged
hypophosphatemia. Such increases in FGF23 may particularly occur depending on the type of
iron carrier.
FGF23 is a significant risk factor for mortality and morbidity in patients with HFREF and
other cardiac populations at risk and may directly cause left ventricular hypertrophy and
dysfunction. Hence, the application of i.v. HD iron may have potentially beneficial effects
on cardiac function but harmful effects via FGF23-induction and hypophosphatemia at the same
time. However, FGF23 metabolism has not yet been evaluated in HFREF patients following i.v.
HD iron.
FGF23 is elevated in patients with chronic kidney disease. Patients with HFREF + CKD =
chronic cardio-renal syndrome are at particular risk regarding elevated morbidity and
mortality. The effects of intravenous HD iron upon phosphate and FGF23 metabolism in patients
with HFREF + CKD is unknown and effects in this setting may be different compared to effects
in patients without pre-existing FGF23 stimulation.
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