Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
Condition: Chronic Heart Failure (CHF); Iron Deficiency
MeSH terms: Heart Failure; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

Summary: 
      ERADAL-HF is a double blinded, multi-centre, prospective, randomized, three arm study,
      enrolled ambulatory patients with chronic heart failure [New York Heart Association (NYHA)
      class II/III], with iron deficiency [defined as ferritin <100 ng/mL, or ferritin 100-300
      ng/mL if transferrin saturation (TSAT) <20%] and haemoglobin (Hb) < 15 g/dL. Patients were
      randomized 1:1:1 to treatment into three arms: a first group treated with intravenous iron
      supplementation, a second treated by intramuscular iron supplementation and the third one
      which have received placebo. These patients were followed-up during a period of 04 weeks.

      The aim of this study is to assess the short term effect of parenteral iron supplementation
      on exercise tolerance and oxidative stress in patients with stable chronic heart failure and
      iron deficiency
    

Detailed description: 
      ERADAL-HF is a double blinded, multi-centre, prospective, randomized, three arm study,
      enrolled ambulatory patients with chronic heart failure [New York Heart Association (NYHA)
      class II/III], with iron deficiency [defined as ferritin <100 ng/mL, or ferritin 100-300
      ng/mL if transferrin saturation (TSAT) <20%] and haemoglobin (Hb) < 15 g/dL. Patients were
      randomized 1:1:1 to treatment into three arms: a first group treated with intravenous iron
      supplementation, a second treated by intramuscular iron supplementation and the third one
      which have received placebo. These patients were followed-up during a period of 04 weeks.

      The aim of this study is to assess the short term effect of parenteral iron supplementation
      on exercise tolerance and oxidative stress in patients with stable chronic heart failure and
      iron deficiency in a sub-Saharan Africa. In addition, it will also try to evaluate its
      effectiveness using the intramuscular route and this with a simplified administration scheme.
    

Intervention name(s): Iron Sucrose IV; Ferric polymaltose hydroxide complex IM; Saline solution
Intervention type(s): Drug; Drug; Other
Intervention description(s): Intervention will consisted of the administration for the IV route.
-The IV route in two doses will be diluted bolus injection of iron or normal saline at day 0 and day 14.; Intervention will consisted of the administration for the IM route. Drug will be given in two series of injection; the first series will began at day 0 and consist of administration of 300 mg of iron per day in intramuscular injection up to the half of the total dose and the second series will began at day 14 for the administration of the other half with the same scheme than the first.; 100 ml i.v. of normal saline administered at Day 0 and at day 14.
Other intervention name(s): Iron Sucrose injection; Iron polymaltose hydroxide complex IM; Placebo intervention
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated; Teferrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: oxidative stress; exercise tolerance; intravenous route (IV); intramuscular route (IM)