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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia

Current Primary Outcome: Functional Capacity [ Time Frame: 90 days ]

Six Minute Walk Test (meter)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Haemoglobin [ Time Frame: 90 days ]
    Haemoglobin level (gr/dL)
  • Echocardiography parameters [ Time Frame: 90 days ]
    Left Ventricle Ejection Fraction
  • Ferritin [ Time Frame: 90 days ]
    Ferritin level (ng/mL)
  • Transferrin saturation [ Time Frame: 90 days ]
    Transferrin saturation (%)


Information By: National Cardiovascular Center Harapan Kita Hospital Indonesia

Dates:
Date Received: December 14, 2016
Date Started: January 2016
Date Completion:
Last Updated: December 19, 2016
Last Verified: December 2016