IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure—Investigator Initiated, Randomized Controlled Trial

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).

Effects of Intravenous Iron Replacement Therapy on Cardiovascular Outcomes in Patients with Heart Failure: A Systematic Review and Meta-Analysis

“…After the removal of 469 duplicates, we screened titles and abstracts of 1202 records. Of these, 31 studies were identified for full-text review and 12 studies [ 6 , 7 , 8 , 15 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ] were included in this review. Studies were excluded primarily as they did not report on cardiovascular mortality or all-cause mortality.…”

“…A total of 11 studies incorporating 2379 patients reported on all-cause mortality [ 5 , 6 , 7 , 8 , 15 , 21 , 23 , 24 , 25 , 26 , 28 ]. Using a fixed effects model, our meta-analysis estimates an odd ratio of 0.88 (95% CI 0.70 to 1.10) based on 218 events/1284 patients in the interventional arm and 233 events/1095 patients in the control arm ( Figure 3 B).…”

“…We included ten studies (3423 patients) reporting on hospitalizations for heart failure [ 6 , 7 , 8 , 15 , 21 , 22 , 24 , 25 , 26 , 27 ]. Our random effects model estimates an odds ratio of 0.49 (95% CI 0.35 to 0.69) favoring intravenous iron replacement ( Figure 3 D).…”

“… Risk of bias assessment. Red (-) indicates high risk and green (+) low risk in the studies included [ 6 , 7 , 8 , 15 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ]. …”

“…( E ) Funnel plot for hospitalizations for heart failure. ( F ) Forrest plot for hospitalizations for heart failure and cardiovascular death using random effects model [ 6 , 7 , 8 , 15 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 ].…”