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

Phase 2

Completed

• Conditions: Heart Failure, Systolic; Iron-deficiency Anemia
• Interventions: Drug: Ferrous Sulfate; Drug: Placebo Oral Capsule

• Registration Number: NCT02998697
• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Study First Posted: 2016-12-20
• Last Update Posted: 2016-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treated Group	Ferrous Sulfate	Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days
Control Group	Placebo Oral Capsule	Systolic heart failure patients received placebo oral capsule t.i.d for 90 days

Primary Outcome Measures

Name	Time	Method
Functional Capacity	90 days	Six Minute Walk Test (meter)

Secondary Outcome Measures

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