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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Criteria

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)