Abstract

Abstract Background and Aims Anemia is highly prevalent in CKD, and most frequently is caused by iron deficiency. Intravenous iron therapy is often and efficiently used, even in non-dialysis CKD patients. Still, experimental data suggested that intravenous iron could alter endothelial function, rising concerns related to the possible cardiovascular long-term effects. In this regard, we clinically assessed the acute impact of a high dose of iron ferric carboxymaltose (FCM), a commonly used iron formulation, on endothelial function in CKD iron-naive non-dialysis patients. Method In this prospective crossover single center study, forty CKD iron-deficient non-dialysis patients [median age 66.5 (56;73) years, 62% female, median estimated glomerular filtration rate 24 (11;36) mL/min, 78% in the very high-risk category according to KDIGO, 90% with hypertension and 40% with diabetes mellitus] were included. The study was approved by Ethics Committee of the UMF “Carol Davila” Bucharest. Pregnancy and breast feeding, anemia of other cause, history of erythropoietin therapy, high-degree inflammation, active malignancies, glomerulonephritis or liver diseases, immunosuppressive therapy, hemoglobin <7g/dl, ferritin > 500 ng/ml and/or transferrin saturation > 50%, baseline flow mediated dilatation (FMD) < 7%, antioxidant supplements and active smoking were exclusion criteria. The effect on endothelial function was clinically assessed by comparing FMD at 15 minutes before and 15 minutes after 2 infusions: first, the comparator (250 mL 0.9% saline), and 24 hours apart, FCM (1000 mg in 250 mL 0.9% saline). FMD was measured using a Doppler ultrasound system according to guidelines recommendations. Wilcoxon paired test was used to test the post- and pre-infusion differences. Results Flow mediated vasodilatation and blood pressure at baseline was similar before each intervention. Neither comparator nor FCM infusion had any effect on acute changes in systolic and diastolic blood pressure. Arterial reactivity was not acutely affected after FCM [ΔFCM 0.01 (-0.35;0.15) versus saline solution 0.001 (-0.4;0.5), p=0.9]. Conclusion A single high dose of ferric carboxymaltose did not acutely impaired endothelial function evaluated by flow mediated vasodilatation, in a CKD non-dialysis cohort.

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