IV sodium ferric gluconate complex resulted in no significant difference in 6-minute walk test change at 3 months (21.6 vs 24.1 meters) or 6 months (-5 vs 46 meters) compared to standard care.
RCT (n=34)
Single-blind
1:1
Does intravenous sodium ferric gluconate complex improve 6-minute walk test distance in patients hospitalized for acute heart failure with iron deficiency?
In a small trial terminated early due to COVID-19, IV sodium ferric gluconate complex did not significantly improve 6-minute walk distance at 3 or 6 months in patients with acute heart failure and iron deficiency.
Tasa de eventos absoluta: 21.6% vs 24.1%
ABSTRACT: Patients with heart failure (HF) with iron deficiency (ID) have worse New York Heart Association class and are at a higher risk of recurrent hospitalizations. Intravenous (IV) iron has been shown to improve exercise ability and reduce hospitalizations. IV sodium ferric gluconate complex (SFGC) has been found to be safe and affordable but has not been studied in this population in a randomized trial. This was a prospective, single-blind, investigator-initiated, randomized controlled trial. Patients admitted for acute heart failure with ID were randomly assigned 1:1 to receive IV SFGC on top of optimal medical treatment. The primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 3 and 6 months. Between September 2019 and May 2021, 34 patients were randomized. 19 patients (55%) were randomized to the treatment arm receiving 125 mg of IV SFGC per day for 3-5 days. COVID-19 was a major barrier to the implementation of the study follow-up protocol, which caused the study to end early. Both groups of patients had similar clinical characteristics, comorbidities, median left ventricular ejection fraction, and rate of death and readmissions due to HF. A higher level of NT-proBNP was observed in patients treated with IV iron (7902 pg/mL vs. 3158, P = 0.04). There was no difference in 6MWT change between groups at 3 months (improvement of 21.6 vs. 24.1 meters) or 6 months (-5 meters vs. 46 meters). In conclusion, IV SFGC-treated patients had a comparable 6-minute walk at 3 and 6 months despite suffering from more severe HF with higher baseline NT-proBNP (NCT04063033).
Marcusohn et al. (Mon,) conducted a rct in Acute heart failure with iron deficiency (n=34). IV sodium ferric gluconate complex (SFGC) vs. Optimal medical treatment was evaluated on Change in the 6-minute walk test (6MWT) from baseline to 3 and 6 months. IV sodium ferric gluconate complex resulted in no significant difference in 6-minute walk test change at 3 months (21.6 vs 24.1 meters) or 6 months (-5 vs 46 meters) compared to standard care.