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

NCT04225728 | Completed Phase 4 DMC

• 1 other identifier: ERADAL-HF
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Heart Failure (CHF); Iron Deficiency

Keywords

oxidative stress; exercise tolerance; intravenous route (IV); intramuscular route (IM)

Outcome Measures

Primary Outcomes (1)

• Variation in 6-minute walk test (6MWT) distance

  Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer

  4 weeks

Secondary Outcomes (7)

• 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

Study Arms (3)

Iron sucrose IV arm

ACTIVE COMPARATOR

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

Drug: Iron Sucrose IV

Ferric polymaltose hydroxide complex IM arm

ACTIVE COMPARATOR

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

Drug: Ferric polymaltose hydroxide complex IM

Placebo arm

PLACEBO COMPARATOR

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

Other: Saline solution

Interventions

Iron Sucrose IV 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.

Also known as: Iron Sucrose injection

Iron sucrose IV arm

Ferric polymaltose hydroxide complex IM 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.

Also known as: Iron polymaltose hydroxide complex IM

Ferric polymaltose hydroxide complex IM arm

Saline solution OTHER

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

Also known as: Placebo intervention

Placebo arm

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CN NGANOU-GNINDJIO, MD, MSc: lead

Study Sites (1)

Yaounde Central Hospital, Cardiology department

Yaoundé, Cameroon

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Ferric Oxide, Saccharated; Saline Solution

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chris Nadege NGANOU-GNINDJIO, MD, MAS

  Yaounde Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr, Principal investigator

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: January 13, 2020
• Study Start: December 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

CA (1)