Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
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
Timeline
- Start
- 2017-12-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ferric polymaltose hydroxide complex | Unknown | 300 mg | Intramuscular |
| Comparator | Iron sucrose | Unknown | — | Intravenous |