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IRON-HF study: a randomized trial to assess the effects of iron in heart failure patients with anemia.

International journal of cardiology
January 1, 1970
Luís Beck-da-Silva et al. (12 authors)
Journal ArticleMulticenter StudyRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

To compare the effects of intravenous (i.v.) iron versus oral (p.o.) iron on functional capacity and anemia correction in heart failure patients with anemia.

Results Summary

I.v. iron improved peak oxygen consumption (peak VO2) by 3.5 ml/kg/min, while p.o. iron showed no improvement. Both i.v. and p.o. iron increased ferritin and transferrin saturation (TSat) levels, with similar hemoglobin increases across all groups.

Population

Anemic heart failure patients with preserved renal function, low transferrin saturation, and low-to-moderately elevated ferritin levels.

Effective Dosage

Iron Sucrose i.v. 200 mg once a week for 5 weeks; ferrous sulfate 200 mg p.o. three times daily for 8 weeks.

Duration

5 weeks for i.v. iron, 8 weeks for p.o. iron.

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Iron Sucrose i.v. 200 mg, once a week, for 5 weeks
increase
peak oxygen consumption (peak VO2)
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
3.5 ml/kg/min
an increment
#1
ferrous sulfate 200 mg p.o. TID, for 8 weeks
no change
peak oxygen consumption (peak VO2)
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
no increment
#2
Iron Sucrose i.v. 200 mg, once a week, for 5 weeks
increase
ferritin
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased significantly
#3
Iron Sucrose i.v. 200 mg, once a week, for 5 weeks
increase
transferrin saturation (TSat)
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased significantly
#4
ferrous sulfate 200 mg p.o. TID, for 8 weeks
increase
ferritin
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased significantly
#5
ferrous sulfate 200 mg p.o. TID, for 8 weeks
increase
transferrin saturation (TSat)
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased significantly
#6
Iron Sucrose i.v. 200 mg, once a week, for 5 weeks
increase
hemoglobin
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased similarly
#7
ferrous sulfate 200 mg p.o. TID, for 8 weeks
increase
hemoglobin
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased similarly
#8
placebo
increase
hemoglobin
anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels
-
increased similarly
#9
Abstract

BACKGROUND: Anemia in heart failure patients and has been associated with increased morbi-mortality. Previous studies have treated anemia in heart failure patients with either erythropoietin alone or combination of erythropoietin and intravenous (i.v.) iron. However, the effect of i.v. or oral (p.o.) iron supplementation alone in heart failure patients with anemia was virtually unknown. AIM: To compare, in a double-blind design, the effects of i.v. iron versus p.o. iron in anemic heart failure patients. METHODS: IRON-HF study was a multicenter, investigator initiated, randomized, double-blind, placebo controlled trial that enrolled anemic heart failure patients with preserved renal function, low transferrin saturation (TSat) and low-to-moderately elevated ferritin levels. Interventions were Iron Sucrose i.v. 200 mg, once a week, for 5 weeks, ferrous sulfate 200 mg p.o. TID, for 8 weeks, or placebo. Primary endpoint was variation of peak oxygen consumption (peak VO2) assessed by ergospirometry over 3 month follow-up. RESULTS: Eighteen patients had full follow-up data. There was an increment of 3.5 ml/kg/min in peak VO2 in the i.v. iron group. There was no increment in peak VO2 in the p.o. iron group. Patients' ferritin and TSat increased significantly in both treated groups. Hemoglobin increased similarly in all groups. CONCLUSION: I.v. iron seems to be superior in improving functional capacity of heart failure patients. However, correction of anemia seems to be at least similar between p.o. iron and i.v. iron supplementation.

Medical Subject Headings (MeSH)
AgedAnemia, Iron-DeficiencyDouble-Blind MethodFemaleFerric CompoundsFerric Oxide, SaccharatedFerrous CompoundsGlucaric AcidHeart FailureHumansInfusions, IntravenousMaleMiddle AgedProspective StudiesTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality80/10
Citation Metrics
Total Citations174
Citations/Year14.5
Relative Citation Ratio5.82
NIH Percentile94.6%
Research Impact Scores
APT Score0.95
Weight Score2.02
Normalized Score0.66
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