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

Launched by CN NGANOU-GNINDJIO, MD, MSC · Jan 8, 2020

Keywords

ClinConnect 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 fo...

Gender

ALL

Eligibility criteria

• 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.