Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia (IRON5)

National Cardiovascular Center Harapan Kita Hospital Indonesia

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure, Systolic

Iron-deficiency Anemia

Treatments

Drug: Placebo Oral Capsule

Drug: Ferrous Sulfate

Study type

Interventional

Funder types

Other

Identifiers

NCT02998697

LB.02.01/VII/077/KEP.033EV

Details and patient eligibility

About

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).

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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)