STUDY OBJECTIVE: To assess the short-term efficacy and safety of an accelerated intravenous iron regimen in hospitalized patients with heart failure and iron deficiency. DESIGN: Prospective, single-arm, open-label study. SETTING: Large tertiary care medical center. PATIENTS: Thirteen patients with New York Heart Association class III-IV heart failure, anemia (hemoglobin level ≤ 12.0 g/dl), and iron deficiency (ferritin level < 100 ng/ml, or ferritin level of 100-300 ng/ml with transferrin saturation < 20%) hospitalized between April 2011 and December 2013. INTERVENTION: All patients received sodium ferric gluconate 250 mg in 100 ml of normal saline intravenously over 2 hours twice/day until the iron deficit was corrected or the patient was discharged. MEASUREMENTS AND MAIN RESULTS: Changes in hematologic parameters were assessed at 1-4 weeks after therapy. Patients received a mean ± standard deviation (SD) total iron dose of 1269 ± 207 mg over 3.4 ± 1.0 days. After a mean ± SD follow-up of 13.1 ± 5.6 days, intravenous iron increased hemoglobin level by 1.2 g/dl (95% confidence interval [CI] 0.45-1.9, p=0.005), ferritin level by 364.2 ng/ml (95% CI 129.7-598.7, p=0.007), and transferrin saturation by 10.5% (95% CI 6.5-14.6%, p<0.001). Changes in hemoglobin level did not correlate with volume status, as determined by differences in body weight. No significant changes in blood pressure or heart rate were observed. Adverse events were few and minor in severity (e.g., nausea, constipation, and abdominal discomfort). CONCLUSION: An accelerated intravenous iron regimen improved hematologic parameters and was well tolerated in hospitalized patients with advanced heart failure. A randomized multicenter trial comparing this regimen with placebo is warranted.
RCT Entities:
STUDY OBJECTIVE: To assess the short-term efficacy and safety of an accelerated intravenous iron regimen in hospitalized patients with heart failure and iron deficiency. DESIGN: Prospective, single-arm, open-label study. SETTING: Large tertiary care medical center. PATIENTS: Thirteen patients with New York Heart Association class III-IV heart failure, anemia (hemoglobin level ≤ 12.0 g/dl), and iron deficiency (ferritin level < 100 ng/ml, or ferritin level of 100-300 ng/ml with transferrin saturation < 20%) hospitalized between April 2011 and December 2013. INTERVENTION: All patients received sodium ferric gluconate 250 mg in 100 ml of normal saline intravenously over 2 hours twice/day until the iron deficit was corrected or the patient was discharged. MEASUREMENTS AND MAIN RESULTS: Changes in hematologic parameters were assessed at 1-4 weeks after therapy. Patients received a mean ± standard deviation (SD) total iron dose of 1269 ± 207 mg over 3.4 ± 1.0 days. After a mean ± SD follow-up of 13.1 ± 5.6 days, intravenous iron increased hemoglobin level by 1.2 g/dl (95% confidence interval [CI] 0.45-1.9, p=0.005), ferritin level by 364.2 ng/ml (95% CI 129.7-598.7, p=0.007), and transferrin saturation by 10.5% (95% CI 6.5-14.6%, p<0.001). Changes in hemoglobin level did not correlate with volume status, as determined by differences in body weight. No significant changes in blood pressure or heart rate were observed. Adverse events were few and minor in severity (e.g., nausea, constipation, and abdominal discomfort). CONCLUSION: An accelerated intravenous iron regimen improved hematologic parameters and was well tolerated in hospitalized patients with advanced heart failure. A randomized multicenter trial comparing this regimen with placebo is warranted.
Authors: Abel Makubi; Johnson Lwakatare; Okechukwu S Ogah; Lars Rydén; Lars H Lund; Julie Makani Journal: Cardiovasc J Afr Date: 2017 Sep/Oct Impact factor: 1.167