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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02998697

Acronym

IRON5

Enrollment

Registered

2016-12-20

Start date

2016-01-31

Completion date

2016-11-30

Last updated

2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic, Iron-deficiency Anemia

Keywords

Systolic Heart Failure, Anemia, Iron Deficiency

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.

Interventions

DRUGFerrous Sulfate

Ferrous sulfate 200 mg t.i.d for 90 days

DRUGPlacebo Oral Capsule

Lactose 200 mg t.i.d for 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Functional Capacity	90 days	Six Minute Walk Test (meter)

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026