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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

Conditions
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Heart Failure, Systolic, Iron-deficiency Anemia

Intervention / Treatment
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* Drug: Ferrous Sulfate
* Drug: Placebo Oral Capsule


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Group<br>Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days | Drug: Ferrous Sulfate<br>* Ferrous sulfate 200 mg t.i.d for 90 days<br>* Other names: Ferrous Sulfate oral capsule;|
| Placebo Comparator: Control Group<br>Systolic heart failure patients received placebo oral capsule t.i.d for 90 days | Drug: Placebo Oral Capsule<br>* Lactose 200 mg t.i.d for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capacity | Six Minute Walk Test (meter) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin | Ferritin level (ng/mL) | 90 days | 
| Transferrin saturation | Transferrin saturation (%) | 90 days | 
| Haemoglobin | Haemoglobin level (gr/dL) | 90 days | 
| Echocardiography parameters | Left Ventricle Ejection Fraction | 90 days | 
| N Terminal-pro Brain Natriuretic Peptide | NT-proBNP level (pg/mL) | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systolic Heart Failure, Anemia, Iron Deficiency