Back to resultsEvaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study (ERADAL-HF)
Primary Purpose
Chronic Heart Failure (CHF), Iron Deficiency
Status
Completed
Phase
Phase 4
Locations
Cameroon
Study Type
Interventional
Intervention
Iron Sucrose IV
Ferric polymaltose hydroxide complex IM
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure (CHF) focused on measuring oxidative stress, exercise tolerance, intravenous route (IV), intramuscular route (IM)
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.
Sites / Locations
- Yaounde Central Hospital, Cardiology department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Iron sucrose IV arm
Ferric polymaltose hydroxide complex IM arm
Placebo arm
Arm Description
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
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
100 ml i.v. of normal saline administered at Day 0 and at day 14.
Outcomes
Primary Outcome Measures
Variation in 6-minute walk test (6MWT) distance
Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer
Secondary Outcome Measures
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Minnesota Living With Heart Failure Questionnaire score at Week 4 adjusted for baseline
Change in serum ferritin concentration
Change in serum ferritin concentration (micromol/l) level from baseline to week 4. By immunology
Change in serum concentration of anti-oxidant markers: Reduced Glutathione (micromol)
Change in serum concentration of anti-oxidant markers from baseline to week 4. By spectrophotometer
Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)
Change in concentration of oxidant marker from baseline to week 4. By spectrophotometer
Change in Left Ventricle Ejection Fraction by Simpson method
Change in Left Ventricle Ejection Fraction (%) by Simpson method on echocardiography from baseline to week 4
Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)
Cost-effectiveness by using the ICER questionnaire between the IV and the IM route
Standard safety assessments
Standard safety assessments: adverse events by questionnaires
Full Information
NCT ID
NCT04225728
First Posted
April 2, 2019
Last Updated
January 8, 2020
Sponsor
CN NGANOU-GNINDJIO, MD, MSc
1. Study Identification
Unique Protocol Identification Number
NCT04225728
Brief Title
Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
Acronym
ERADAL-HF
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CN NGANOU-GNINDJIO, MD, MSc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure (CHF), Iron Deficiency
Keywords
oxidative stress, exercise tolerance, intravenous route (IV), intramuscular route (IM)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron sucrose IV arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Ferric polymaltose hydroxide complex IM arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
100 ml i.v. of normal saline administered at Day 0 and at day 14.
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose IV
Other Intervention Name(s)
Iron Sucrose injection
Intervention Description
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
Intervention Name(s)
Ferric polymaltose hydroxide complex IM
Other Intervention Name(s)
Iron polymaltose hydroxide complex IM
Intervention Description
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
Other
Intervention Name(s)
Saline solution
Other Intervention Name(s)
Placebo intervention
Intervention Description
100 ml i.v. of normal saline administered at Day 0 and at day 14.
Primary Outcome Measure Information:
Title
Variation in 6-minute walk test (6MWT) distance
Description
Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Description
Minnesota Living With Heart Failure Questionnaire score at Week 4 adjusted for baseline
Time Frame
4 weeks
Title
Change in serum ferritin concentration
Description
Change in serum ferritin concentration (micromol/l) level from baseline to week 4. By immunology
Time Frame
4 weeks
Title
Change in serum concentration of anti-oxidant markers: Reduced Glutathione (micromol)
Description
Change in serum concentration of anti-oxidant markers from baseline to week 4. By spectrophotometer
Time Frame
4 weeks
Title
Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)
Description
Change in concentration of oxidant marker from baseline to week 4. By spectrophotometer
Time Frame
4 weeks
Title
Change in Left Ventricle Ejection Fraction by Simpson method
Description
Change in Left Ventricle Ejection Fraction (%) by Simpson method on echocardiography from baseline to week 4
Time Frame
4 weeks
Title
Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)
Description
Cost-effectiveness by using the ICER questionnaire between the IV and the IM route
Time Frame
4 weeks
Title
Standard safety assessments
Description
Standard safety assessments: adverse events by questionnaires
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Nadege NGANOU-GNINDJIO, MD, MAS
Organizational Affiliation
Yaounde Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yaounde Central Hospital, Cardiology department
City
Yaoundé
Country
Cameroon
12. IPD Sharing Statement
Learn more about this trial
Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
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