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

NCT ID: NCT04225728

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-06-01

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.

Conditions

Chronic Heart Failure (CHF); Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Iron Sucrose IV

Intervention Type: DRUG

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.

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

Group Type: ACTIVE_COMPARATOR

Ferric polymaltose hydroxide complex IM

Intervention Type: DRUG

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.

Placebo arm

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

Group Type: PLACEBO_COMPARATOR

Saline solution

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Saline solution

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

Intervention Type: OTHER

Other Intervention Names

Iron Sucrose injection; Iron polymaltose hydroxide complex IM; Placebo intervention

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CN NGANOU-GNINDJIO, MD, MSc

OTHER_GOV

Sponsor Role: lead

Responsible Party

CN NGANOU-GNINDJIO, MD, MSc

Dr, Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chris Nadege NGANOU-GNINDJIO, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

Yaounde Central Hospital

Locations

Yaounde Central Hospital, Cardiology department

Yaoundé, , Cameroon

Countries

Cameroon

Other Identifiers

ERADAL-HF

Identifier Type: -

Identifier Source: org_study_id