Chronic Heart Failure (CHF)Phase 4ERADAL-HFNCT04225728
Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study
A Phase 4 study testing Iron Sucrose IV, Ferric polymaltose hydroxide complex IM and Saline solution in people with Chronic Heart Failure (CHF) and Iron Deficiency, run by CN NGANOU-GNINDJIO, MD, MSc at 1 site in Cameroon.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Chronic Heart Failure (CHF), Iron Deficiency
- What is being tested?
- Iron Sucrose IV, Ferric polymaltose hydroxide complex IM and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCameroon
- Study dates
- 1 Dec 2017to 1 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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
Read the 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
- Being tested
- Iron Sucrose IV, Ferric polymaltose hydroxide complex IM, Saline solution
- Keywords
- oxidative stress, exercise tolerance, intravenous route (IV), intramuscular route (IM)
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Sucrose IVDrug
Also called Iron Sucrose injection
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 IMDrug
Also called Iron 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.
Saline solutionOther
Also called Placebo intervention
100 ml i.v. of normal saline administered at Day 0 and at day 14.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in 6-minute walk test (6MWT) distance
Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer
Measured: 4 weeks
Secondary outcomes (7)
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
Measured: 4 weeks
Change in serum ferritin concentration
Change in serum ferritin concentration (micromol/l) level from baseline to week 4. By immunology
Measured: 4 weeks
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
Measured: 4 weeks
Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)
Change in concentration of oxidant marker from baseline to week 4. By spectrophotometer
Measured: 4 weeks
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
Measured: 4 weeks
Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)
Cost-effectiveness by using the ICER questionnaire between the IV and the IM route
Measured: 4 weeks
Standard safety assessments
Standard safety assessments: adverse events by questionnaires
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Dec 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure (CHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- CN NGANOU-GNINDJIO, MD, MSc
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, CN NGANOU-GNINDJIO, MD, MSc, Yaounde Central Hospital
- Investigators
- Chris Nadege NGANOU-GNINDJIO, MD, MAS, Principal investigator, Yaounde Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225728
- Sponsor's protocol ID
- ERADAL-HF
- Acronym
- ERADAL-HF
- Status last verified
- Jan 2020
- First submitted
- 2 Apr 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04225728
- Acronym / sponsor ID
- ERADAL-HF / ERADAL-HF
- Conditions
- Chronic Heart Failure (CHF), Iron Deficiency
- Keywords
- oxidative stress, exercise tolerance, intravenous route (IV), intramuscular route (IM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- CN NGANOU-GNINDJIO, MD, MScOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron sucrose IV arm | Active comparator | Drug: Iron Sucrose IVPerfusion of diluted iron sucrose i.v. in two weeks. Half of the total dose at Day 0 and the other half at Day 14 |
| Ferric polymaltose hydroxide complex IM arm | Active comparator | Drug: Ferric polymaltose hydroxide complex IMInjection 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 |
| Placebo arm | Placebo comparator | Other: Saline solution100 ml i.v. of normal saline administered at Day 0 and at day 14. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron Sucrose IVAlso: Iron Sucrose injectionIntervention 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. | Drug | Iron sucrose IV arm |
| Ferric polymaltose hydroxide complex IMAlso: Iron polymaltose hydroxide complex IMIntervention 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. | Drug | Ferric polymaltose hydroxide complex IM arm |
| Saline solutionAlso: Placebo intervention100 ml i.v. of normal saline administered at Day 0 and at day 14. | Other | Placebo arm |
Primary outcome
Variation in 6-minute walk test (6MWT) distance
Time frame: 4 weeks
Variation in 6MWT in meter distance from the baseline to week 4. By using pedometer
7 secondary outcomes
Change in quality of life assessed by the Minnesota Living With Heart Failure Questionnaire (MLWHFQ)
Time frame: 4 weeks
Change in serum ferritin concentration
Time frame: 4 weeks
Change in serum concentration of anti-oxidant markers: Reduced Glutathione (micromol)
Time frame: 4 weeks
Change in serum concentration of oxidant marker: Malondialdehyde (micromol/l)
Time frame: 4 weeks
Change in Left Ventricle Ejection Fraction by Simpson method
Time frame: 4 weeks
Cost-effectiveness by using the Incremental Cost-effectiveness Ratio (ICER)
Time frame: 4 weeks
Standard safety assessments
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Related trials for Chronic Heart Failure (CHF)
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Nadege NGANOU-GNINDJIO, MD, MAS principal investigator
Yaounde Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron Sucrose IV, Ferric polymaltose hydroxide complex IM and Saline solution in people with Chronic Heart Failure (CHF) and Iron Deficiency, run by CN NGANOU-GNINDJIO, MD, MSc at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in 6-minute walk test (6MWT) distance (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.