NCT04225728

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

Rationale and Design of Ferric Polymaltose Hydroxide and Iron Sucrose Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: CN NGANOU-GNINDJIO, MD, MSc · Other Government
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure (CHF)
• Iron Deficiency

Interventions

Type	Name	Description
DRUG	Iron Sucrose IV	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.
DRUG	Ferric polymaltose hydroxide complex IM	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.
OTHER	Saline solution	100 ml i.v. of normal saline administered at Day 0 and at day 14.

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2020-01-13
• Last updated: 2020-01-13

Locations

1 site across 1 country: Cameroon