Clinical trial NCT04225728: Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure (CHF)
Iron Deficiency
Keywords: oxidative stress
exercise tolerance
intravenous route (IV)
intramuscular route (IM)
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-13
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Variation in 6-minute walk test (6MWT) distance
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
timeFrame: 4 weeks
measure: Change in serum ferritin concentration
timeFrame: 4 weeks
measure: Change in serum concentration of anti-oxidant markers: Reduced Glutathione (micromol)
timeFrame: 4 weeks
measure: Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)
timeFrame: 4 weeks
measure: Change in Left Ventricle Ejection Fraction by Simpson method
timeFrame: 4 weeks
measure: Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)
timeFrame: 4 weeks
measure: Standard safety assessments
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Yaounde Central Hospital, Cardiology department
Study officials:
affiliation: Yaounde Central Hospital
name: Chris Nadege NGANOU-GNINDJIO, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: