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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Variation in 6-minute walk test (6MWT) distance
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Iron sucrose IV arm
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
Intervention: Iron Sucrose IV (Drug)
Ferric polymaltose hydroxide complex IM arm
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
Intervention: Ferric polymaltose hydroxide complex IM (Drug)
Placebo arm
100 ml i.v. of normal saline administered at Day 0 and at day 14.
Intervention: Saline solution (Other)
Outcomes
Primary Outcomes
Variation in 6-minute walk test (6MWT) distance
Time Frame: 4 weeks
Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer
Secondary Outcomes
- Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)(4 weeks)
- Change in serum ferritin concentration(4 weeks)
- Change in serum concentration of anti-oxidant markers: Reduced Glutathione (micromol)(4 weeks)
- Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)(4 weeks)
- Change in Left Ventricle Ejection Fraction by Simpson method(4 weeks)
- Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)(4 weeks)
- Standard safety assessments(4 weeks)
Investigators
CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Yaounde Central Hospital