The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).
The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF \< 50%) with IDA (Ferritin \< 100 ng/mL or 100-300 ng/mL with Tsat \< 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Ferrous sulfate 200 mg t.i.d for 90 days
Lactose 200 mg t.i.d for 90 days
Functional Capacity
Six Minute Walk Test (meter)
Time frame: 90 days
Ferritin
Ferritin level (ng/mL)
Time frame: 90 days
Transferrin saturation
Transferrin saturation (%)
Time frame: 90 days
Haemoglobin
Haemoglobin level (gr/dL)
Time frame: 90 days
Echocardiography parameters
Left Ventricle Ejection Fraction
Time frame: 90 days
N Terminal-pro Brain Natriuretic Peptide
NT-proBNP level (pg/mL)
Time frame: 90 days
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