Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

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.

Inclusion criteria

• Age ≥ 18 year old
• Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
• New York Heart Association (NYHA) functional class II-III able to perform 6MWT
• LVEF < 50%
• On heart failure therapy
• Haemoglobin (Hb) < 13 gr/dL (male); Hb < 12 gr/dL (female) and > 8 gr/dL
• Ferritin < 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) < 20%
• Agree to participate

Exclusion criteria

• History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
• History of myocardial revascularization (CABG/PCI) within 3 month
• Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
• Know to have allergic reaction to Ferrous sulfate
• History of intravenous iron administration within 1 month
• Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT)
• estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2
• NT-proBNP > 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP < 30% from baseline
• Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)> 3x normal value
• Moderate to severe primary valvular heart disease
• Congenital heart disease
• Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)