Heart FailurePhase 4NCT04063033
IV Iron in Acute Decompensated Heart Failure
A Phase 4 study testing IV iron - Sodium Ferric Gluconate Complex in people with Heart Failure, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The study aims Compare the effect of addition of IV FERRLECITR (ferric gluconate) to standard therapy to standard therapy alone (without any IV iron treatment) in patients admitted with acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- IV iron - Sodium Ferric Gluconate Complex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2019to 31 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted due to acute decompensated heart failure to internal medicine department H or cardiology department.
- Must meet two of the following criteria :
- NT pro BNP > 300 pg/ml (>800 pg/ml in the presence of Atrial Fibrillation).
- Peripheral pitting edema,
- Jugular Venous Distention,
- pulmonary edema/congestion according to physical examination or Chest X-ray.
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- IV furosemide treatment on admission to ER or internal ward/cardiology department.
- Hb level 8-14 mg/dl on admission.
- Iron stores: Ferritin <100 or Ferritin 100-300 and Transferrin saturation < 20%.
- No evidence of active bleeding.
- Patient provided informed consent.
Who cannot join
- Cardiogenic shock or any other condition requiring IV vasopressors.
- Previous allergy or anaphylaxis due to IV Iron.
- Active malignancy undergoing treatment.
- Status post major surgery involving substantial blood loss in the past 3 months.
- Indication for Blood transfusion.
- Infection indicating IV antibiotics.
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- History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- hemolytic anemia.
- History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
- Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.
- Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate >110 beats per minute [bpm]); uncontrolled symptomatic brady- or tachyarrhythmias.
- Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
- Pregnant or breastfeeding.
- Inability to comprehend study protocol.
- Parallel participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Bilnded Controlled Trial Comparing The Effect of IV Sodium Ferric Gluconate Complex (FERRLECIT R) on Outcome Patients Admitted Due To Acute Decompansated Heart Failure With Iron Deficiency
The study aims Compare the effect of addition of IV FERRLECITR (ferric gluconate) to standard therapy to standard therapy alone (without any IV iron treatment) in patients admitted with acute decompensated heart failure.
Read the detailed description
Heart Failure (HF) constitutes one of the biggest burdens on the public health system, with incidence of 20 per 1000 persons above the age of 65 and up to 80 per 1000 persons above 85 years of age. Acute decompensated heart failure (ADHF) is the most common cause of hospitalizations among patients above the age of 65. Even with the advances in the treatment and management of HF, the prognosis of these patients remains poor. HF results in impaired quality of life (QoL), repeated hospitalizations and poor life expectancy.
Iron deficiency (ID) is a common comorbidity in HF patients, and is associated with poor outcome, worsening of New York Heart Association (NYHA) Class, and re-hospitalizations. While the mechanisms and pathophysiology of ID in HF is not well understood, it is presumed to be a combination of impaired absorption, renal dysfunction, hemodilution and drugs that are used for the treatment of HF.
The advantages of (intra-venous) IV ferric carboxymaltose to patients with reduced ejection fraction (HFrEF) with stable chronic heart failure and functional ID has been shown to reduce the risk of hospitalizations up to 60%, improve symptoms, exercise tolerance, functional capacity and overall QoL . Accordingly, the latest 2016 ESC Guidelines recommended the treatment in patients with HfrEF with reduced ejection fraction (HFrEF) and ID (Class IIA,LOC A).
The two major, placebo-controlled studies, mentioned above (CONFIRM-AF and FAIR-AF) have demonstrated the positive outcomes after correction of ID in stable HF patients, with a well-tolerated IV substance. However, there is no data today concerning the role of IV iron repletion in patients with decompensated HF and preserved EF. Furthermore, previous studies excluded a substantial portion of the HFrEF population recently admitted with (acute decompensated heart failure) ADHF and diagnosed with ID.
The effect of treating iron deficiency on quality of life an functional status has already been studied and found useful with various types of intravenous iron in the chronic kidney disease and inflammatory bowel disease.
In this study we aim to examine the effect of IV iron (ferric gluconate) which is a more affordable IV Iron on patients admitted due to acute heart failure with minimal exclusion criterias.
- Conditions
- Heart Failure
- Being tested
- IV iron - Sodium Ferric Gluconate Complex
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV iron - Sodium Ferric Gluconate ComplexDrug
Also called IV Ferrlecit
IV Iron will be administered 125 mg each day, to 3-5 days during hospitalisation.
| Study group | Role | What they receive |
|---|---|---|
| IV Iron treatment | Experimental | Patients will be administered IV Iron for 3-5 days. 125 mg per day. Receives: Drug: IV iron - Sodium Ferric Gluconate Complex |
| No IV Iron treatment | No intervention | Patients will receive standard treatment for heart failure without IV Iron. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
The functional capacity will be evaluated by the 6 minute walk test at baseline,12 weeks and 24 weeks follow up.
Measured: 12 and 24 Weeks
Secondary outcomes (3)
Change in NYHA
Change in NYHA from baseline to 12 and 24 weeks
Measured: 12 and 24 weeks
All cause mortality
Incidence of all cause mortality up to 1 year followup
Measured: 1 Year
Hospitalizations due to heart failure.
Incidence of hospitalisations due to heart failure up to 1 year followup
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Sep 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Model description
- Randomisation to two groups, One receiving IV Iron on top of standard therapy while admitted to the hospital and the other receiving only standard therapy for acute heart failure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erez Marcusohn MD, Rambam Health Care Campus
- Investigators
- Erez Marcusohn, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063033
- Sponsor's protocol ID
- 0290-19 RMB
- Status last verified
- Apr 2023
- First submitted
- 18 Aug 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marcusohn E, Borreda I, Hellman Y, Habib M, Bahouth F, Epstein D, Zukermann R. IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure-Investigator Initiated, Randomized Controlled Trial. J Cardiovasc Pharmacol. 2022 Aug 1;80(2):194-196. doi: 10.1097/FJC.0000000000001287.
PubMed 35503997
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Bilnded Controlled Trial Comparing The Effect of IV Sodium Ferric Gluconate Complex (FERRLECIT R) on Outcome Patients Admitted Due To Acute Decompansated Heart Failure With Iron Deficiency
- ClinicalTrials.gov ID
- NCT04063033
- Acronym / sponsor ID
- 0290-19 RMB
- Conditions
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Aug 2019 (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.
The study aims Compare the effect of addition of IV FERRLECITR (ferric gluconate) to standard therapy to standard therapy alone (without any IV iron treatment) in patients admitted with acute decompensated heart failure.
Detailed description
Heart Failure (HF) constitutes one of the biggest burdens on the public health system, with incidence of 20 per 1000 persons above the age of 65 and up to 80 per 1000 persons above 85 years of age. Acute decompensated heart failure (ADHF) is the most common cause of hospitalizations among patients above the age of 65. Even with the advances in the treatment and management of HF, the prognosis of these patients remains poor. HF results in impaired quality of life (QoL), repeated hospitalizations and poor life expectancy.
Iron deficiency (ID) is a common comorbidity in HF patients, and is associated with poor outcome, worsening of New York Heart Association (NYHA) Class, and re-hospitalizations. While the mechanisms and pathophysiology of ID in HF is not well understood, it is presumed to be a combination of impaired absorption, renal dysfunction, hemodilution and drugs that are used for the treatment of HF.
The advantages of (intra-venous) IV ferric carboxymaltose to patients with reduced ejection fraction (HFrEF) with stable chronic heart failure and functional ID has been shown to reduce the risk of hospitalizations up to 60%, improve symptoms, exercise tolerance, functional capacity and overall QoL . Accordingly, the latest 2016 ESC Guidelines recommended the treatment in patients with HfrEF with reduced ejection fraction (HFrEF) and ID (Class IIA,LOC A).
The two major, placebo-controlled studies, mentioned above (CONFIRM-AF and FAIR-AF) have demonstrated the positive outcomes after correction of ID in stable HF patients, with a well-tolerated IV substance. However, there is no data today concerning the role of IV iron repletion in patients with decompensated HF and preserved EF. Furthermore, previous studies excluded a substantial portion of the HFrEF population recently admitted with (acute decompensated heart failure) ADHF and diagnosed with ID.
The effect of treating iron deficiency on quality of life an functional status has already been studied and found useful with various types of intravenous iron in the chronic kidney disease and inflammatory bowel disease.
In this study we aim to examine the effect of IV iron (ferric gluconate) which is a more affordable IV Iron on patients admitted due to acute heart failure with minimal exclusion criterias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation to two groups, One receiving IV Iron on top of standard therapy while admitted to the hospital and the other receiving only standard therapy for acute heart failure.
| Arm | Type | Receives |
|---|---|---|
| IV Iron treatment | Experimental | Drug: IV iron - Sodium Ferric Gluconate ComplexPatients will be administered IV Iron for 3-5 days. 125 mg per day. |
| No IV Iron treatment | No intervention | –Patients will receive standard treatment for heart failure without IV Iron. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients admitted due to acute decompensated heart failure to internal medicine department H or cardiology department.
- Hb level 8-14 mg/dl on admission.
- Iron stores: Ferritin <100 or Ferritin 100-300 and Transferrin saturation < 20%.
- No evidence of active bleeding.
- Patient provided informed consent.
Key exclusion criteria (15 listed)
- Cardiogenic shock or any other condition requiring IV vasopressors.
- Previous allergy or anaphylaxis due to IV Iron.
- Active malignancy undergoing treatment.
- Status post major surgery involving substantial blood loss in the past 3 months.
- Indication for Blood transfusion.
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 |
|---|---|---|
| IV iron - Sodium Ferric Gluconate ComplexAlso: IV FerrlecitIV Iron will be administered 125 mg each day, to 3-5 days during hospitalisation. | Drug | IV Iron treatment |
Primary outcome
Functional Capacity
Time frame: 12 and 24 Weeks
The functional capacity will be evaluated by the 6 minute walk test at baseline,12 weeks and 24 weeks follow up.
3 secondary outcomes
Change in NYHA
Time frame: 12 and 24 weeks
All cause mortality
Time frame: 1 Year
Hospitalizations due to heart failure.
Time frame: 1 year
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 11 Apr 2023.
- Derived from this study: PubMed 35503997Marcusohn E, Borreda I, Hellman Y, Habib M, Bahouth F, Epstein D, Zukermann R. IV Sodium Ferric Gluconate Complex in Patients With Iron Deficiency Hospitalized due to Acute Heart Failure-Investigator Initiated, Randomized Controlled Trial. J Cardiovasc Pharmacol. 2022 Aug 1;80(2):194-196. doi: 10.1097/FJC.0000000000001287.
- Individual participant dataSharing planned: No
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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.
Erez Marcusohn, MD principal investigator
Rambam Health Care Campus
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 IV iron - Sodium Ferric Gluconate Complex in people with Heart Failure, run by Rambam Health Care Campus at 1 site in Israel.
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 11 inclusion and 15 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 11 Apr 2023. 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 Israel. 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. 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?
Functional Capacity (time frame: 12 and 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063033, which also lists 1 linked publication.
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 11 Apr 2023.