drugset / Trial / NCT04225728

Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study

NCT04225728

Phase 4 Completed 45 enrolled CN NGANOU-GNINDJIO, MD, MSc
RandomizedParallel-groupDouble-blindTreatment

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

EvaluationDrugModalityDoseRoute
Comparator Ferric polymaltose hydroxide complex Unknown 300 mg Intramuscular
Comparator Iron sucrose Unknown Intravenous