Journal of cardiovascular medicine (Hagerstown, Md.) · 2026
The effect of intravenous sodium ferric gluconate complex (Ferrlecit) on outcomes of patients undergoing transcatheter aortic valve implantation: a prospective randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Bar Omer, Zukermann Robert, Halhal Basheer, Marcusohn Erez
Аннотация
AIMS: The aim of this trial was to evaluate whether intravenous sodium ferric gluconate could provide benefit beyond transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis.
METHODS AND RESULTS: Between 1 October 2020 and 1 July 2023, we conducted an investigator-initiated, single-center, randomized, single-blind, placebo-controlled trial enrolling patients electively admitted for TAVI due to severe symptomatic aortic stenosis. Patients were randomly assigned to receive intravenous sodium ferric gluconate or a placebo before the procedure and were followed for up to 3 months. After screening, 44 patients were included: 20 patients randomized to intravenous sodium ferric gluconate complex treatment and 24 patients to placebo. There was no difference in the baseline-adjusted 6-min walk distance between the two treatment arms ( P = 0.215). Quality-of-life measures such as Kansas City Cardiomyopathy Questionnaire score and New York Heart Association class did not differ between the treatment arms.
CONCLUSION: Treatment with intravenous sodium ferric gluconate did not provide clinical benefit beyond TAVI in patients with severe aortic stenosis.Clinical Trial Registration: ClinicalTrials.gov NCT04797832.
METHODS AND RESULTS: Between 1 October 2020 and 1 July 2023, we conducted an investigator-initiated, single-center, randomized, single-blind, placebo-controlled trial enrolling patients electively admitted for TAVI due to severe symptomatic aortic stenosis. Patients were randomly assigned to receive intravenous sodium ferric gluconate or a placebo before the procedure and were followed for up to 3 months. After screening, 44 patients were included: 20 patients randomized to intravenous sodium ferric gluconate complex treatment and 24 patients to placebo. There was no difference in the baseline-adjusted 6-min walk distance between the two treatment arms ( P = 0.215). Quality-of-life measures such as Kansas City Cardiomyopathy Questionnaire score and New York Heart Association class did not differ between the treatment arms.
CONCLUSION: Treatment with intravenous sodium ferric gluconate did not provide clinical benefit beyond TAVI in patients with severe aortic stenosis.Clinical Trial Registration: ClinicalTrials.gov NCT04797832.