Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study (ERADAL-HF)

CN NGANOU-GNINDJIO, MD, MSc

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency; Chronic Heart Failure (CHF)

Treatments: Drug: Iron Sucrose IV; Drug: Ferric polymaltose hydroxide complex IM; Other: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04225728

ERADAL-HF

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with stable CHF (NYHA II/III functional class)
• Screening serum ferritin <100 ng/mL or 100-300 ng/mL with transferrin saturation <20%.
• Haemoglobin < 15 g/dl ;
• On optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). In general, optimal pharmacological treatment should include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated.
• Subject must be capable of completing the 6MWT
• Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion criteria

• Subject has known sensitivity to any of the products to be administered during dosing.
• History of acquired iron overload.
• History of erythropoietin-stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization.
• Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron <75 mg/day is permitted.
• Body weight ≤35 kg.
• Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
• Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range
• Subject will not be available for all protocol-specified assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Iron sucrose IV arm

Active Comparator group

Description:

Perfusion of diluted iron sucrose i.v. in two weeks. Half of the total dose at Day 0 and the other half at Day 14

Treatment:

Drug: Iron Sucrose IV

Ferric polymaltose hydroxide complex IM arm

Active Comparator group

Description:

Injection in two series, begin at Day 0 and the second at Day 14. In each series, we administered 300 mg of iron IM until reach half of the dose

Treatment:

Drug: Ferric polymaltose hydroxide complex IM

Placebo arm

Placebo Comparator group

Description:

100 ml i.v. of normal saline administered at Day 0 and at day 14.

Treatment:

Other: Saline solution