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Randomized Controlled Trial
. 2022 Nov 22;17(1):81.
doi: 10.5334/gh.1151. eCollection 2022.

Oral Ferrous Sulphate Improves Functional Capacity on Heart Failure Patients with Iron Deficiency Anemia

Affiliations
Randomized Controlled Trial

Oral Ferrous Sulphate Improves Functional Capacity on Heart Failure Patients with Iron Deficiency Anemia

Lita Dwi Suryani et al. Glob Heart. .

Abstract

Background: Iron deficiency anemia (IDA) in heart failure (HF) is associated with poor functional capacity. Several studies reported the benefit of iron therapy in HF with IDA on improving functional capacity. Therefore, we attempt to investigate the effect of oral iron supplementation on functional capacity in HF patients with IDA.

Results: A double blind randomized controlled trial was conducted in National Cardiovascular Center Harapan Kita Hospital Universitas Indonesia. A total of 54 HFREF patients with IDA were enrolled and randomized to either oral Ferrous Sulphate (FS) 200 mg three times a day or placebo with 1:1 ratio for 12 weeks. Primary outcome was functional capacity measured by a six-minute walk test. There were 41 participants completed the study (FS n = 22, placebo n = 19). Ferrous sulphate significantly improved functional capacity changes (46.23 ± 35 m vs -13.7 ± 46 m, p < 0.001, CI -86.8 to -33.2) compared with placebo groups respectively after 12 weeks intervention.

Conclusions: Oral FS supplementation for 12 weeks significantly improved functional capacity in HF patients with IDA.

Trial registration: clinicaltrials.gov, NCT02998697. Registered 14 December 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02998697.

Keywords: Functional capacity; Heart failure; Iron deficiency anemia; Oral ferrous sulphate.

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Conflict of interest statement

The authors have no competing interests to declare.

Figures

A workflow diagram on getting the 19 placebo subjects and 22 ferrous subjects
Figure 1
Consort diagram flow of this study. HF: Heart failure, eGFR: estimated glomerular filtration rate, 6MWT: 6-minute walk test.
Four diagrams showing that ferrous sulphate was significantly better than placebo on 6MWT FC, Haemolglobin, Ferritin, & Transferrin saturation after 12 weeks intervention
Figure 2
6MWT functional capacity, haemoglobin, and iron profiles after 12 weeks intervention. A. Significant functional capacity improvement in FS group compare to placebo. B–D. Ferrous sulphate significantly increase haemoglobin, ferritin, and transferrin saturation, and levels respectively compared to placebo.
Two diagrams showing that ferrous sulphate was not significantly better than placebo on NT-pro BNP level & LVEF after 12 weeks intervention
Figure 3
NT-pro BNP and LVEF after 12 weeks intervention. A–B. No significant NT-pro BNP and LVEF respectively between both groups after 12 weeks intervention.

References

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