Iron Deficiency Anemia Due to Blood LossPhase 4NCT04797832
IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI
A Phase 4 study testing IV Sodium Ferric Gluconate Complex in people with Iron Deficiency Anemia Due to Blood Loss and Aortic Stenosis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia Due to Blood Loss, Aortic Stenosis
- What is being tested?
- IV Sodium Ferric Gluconate Complex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Oct 2020to 31 Oct 2024
- 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 for TAVI.
- Hb level 8-14 mg/dl on admission.
- No evidence of active bleeding.
- Patient provided informed consent.
- The patient is able to walk without support for 6 minutes.
- LVEF >= 45%
Who cannot join
- 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.
- Infection indicating IV antibiotics, not including prophylaxis for TAVI.
- History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Hemolytic anemia.
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- 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.
- Musculoskeletal limitation that, in the judgement of the investigator, would impair 6-minute walk.
- Pregnant or breastfeeding.
- Inability to comprehend study protocol.
- Parallel participation in another clinical trial.
- During TAVI or the day following the procedure:
- Major complication of death. II. Cardiogenic shock or any other condition requiring IV vasopressors. III. Major bleeding according to BARC 2 criteria or above. IV. Need for more than 2 pack cells during or after the procedure.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Medical Center
Haifa
Erez Marcusohn, MD, 972503482952, e_marcusohn@rambam.health.gov.il
Robert Zukerman, MD, 972545401254, r_zukerman@rambam.health.gov.il
About this study
Official title: Randomized Bilnded Controlled Trial Comparing The Effect of IV Sodium Ferric Gluconate Complex (FERRLECIT R) on Outcome of Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients.
The investigators predict, that as IV iron will improve symptoms, quality of life and exercise tolerance in this group of patients.
Read the detailed description
Iron deficiency (ID) among patients undergoing transcatheter aortic valve implantation (TAVI) is common (54%-79% .These patients suffer from higher mortality, unplanned readmission for worsening heart failure or red blood cell transfusions during the first year after TAVI.IV Iron therapy was found to be feasible in the 56 patients who were treated and showed improvement in symptoms at 30 days follow-up.Anemia in TAVI patients is multifactorial, related to advanced age, frailty, coagulopathy, medications, kidney disease, bleeding, inflammation and ID. The most treatable part is ID.
Iron deficiency (ID) is a common comorbidity in other diseases. In heart failure (HF) patients, it 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). No guidelines recommend IV iron supplementation in TAVI patients.
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. Furthermore, the effect of treating iron deficiency on quality of life and functional status has already been studied and found useful with various types of intravenous iron in the chronic kidney disease and inflammatory bowel disease.The effect of treating with oral iron supplements has been studied in HF patients with no difference in exercise capacity, symptoms, NT pro BNP, iron stores, Hemoglobin levels or V02 compared to placebo.
In this study the investigators aim to examine the effect of IV iron (ferric gluconate) which is a more affordable IV Iron on patients with ID admitted for TAVI. No randomized trial has been published in this topic to this day.
- Being tested
- IV Sodium Ferric Gluconate Complex
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Sodium Ferric Gluconate ComplexDrug
Also called IV Ferrlecit
125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | 100 patients receiving IV Iron during index hospitalisation. Receives: Drug: IV Sodium Ferric Gluconate Complex |
| No treatment | No intervention | 100 patients not receiving IV Iron above standout treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk change at 1 month.
6-minute walk change (meters) between baseline and 1 month follow-up.
Measured: 30 days.
6-minute walk change at one year.
6-minute walk change (meters) between baseline and 1 year follow-up.
Measured: One year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start18 Oct 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
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 Iron Deficiency Anemia Due to Blood LossStudies 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
- Single blinded randomized control trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
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, Cardiology Department, Rambam Health Care Campus,Haifa,Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797832
- Sponsor's protocol ID
- 0438-20 RMB
- Status last verified
- Oct 2022
- First submitted
- 9 Mar 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bar O, Zukermann R, Halhal B, Marcusohn E. The effect of intravenous sodium ferric gluconate complex (Ferrlecit) on outcomes of patients undergoing transcatheter aortic valve implantation: a prospective randomized controlled trial. J Cardiovasc Med (Hagerstown). 2026 May 1;27(5):389-397. doi: 10.2459/JCM.0000000000001867. Epub 2026 Mar 17.
PubMed 41870899
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. 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 of Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT04797832
- Acronym / sponsor ID
- 0438-20 RMB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 18 Oct 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 15 Mar 2021 (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.
Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients.
The investigators predict, that as IV iron will improve symptoms, quality of life and exercise tolerance in this group of patients.
Detailed description
Iron deficiency (ID) among patients undergoing transcatheter aortic valve implantation (TAVI) is common (54%-79% .These patients suffer from higher mortality, unplanned readmission for worsening heart failure or red blood cell transfusions during the first year after TAVI.IV Iron therapy was found to be feasible in the 56 patients who were treated and showed improvement in symptoms at 30 days follow-up.Anemia in TAVI patients is multifactorial, related to advanced age, frailty, coagulopathy, medications, kidney disease, bleeding, inflammation and ID. The most treatable part is ID.
Iron deficiency (ID) is a common comorbidity in other diseases. In heart failure (HF) patients, it 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). No guidelines recommend IV iron supplementation in TAVI patients.
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. Furthermore, the effect of treating iron deficiency on quality of life and functional status has already been studied and found useful with various types of intravenous iron in the chronic kidney disease and inflammatory bowel disease.The effect of treating with oral iron supplements has been studied in HF patients with no difference in exercise capacity, symptoms, NT pro BNP, iron stores, Hemoglobin levels or V02 compared to placebo.
In this study the investigators aim to examine the effect of IV iron (ferric gluconate) which is a more affordable IV Iron on patients with ID admitted for TAVI. No randomized trial has been published in this topic to this day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single blinded randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: IV Sodium Ferric Gluconate Complex100 patients receiving IV Iron during index hospitalisation. |
| No treatment | No intervention | –100 patients not receiving IV Iron above standout treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (14 listed)
- Major complication of death. II. Cardiogenic shock or any other condition requiring IV vasopressors. III. Major bleeding according to BARC 2 criteria or above. IV. Need for more than 2 pack cells during or after the procedure.
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 Sodium Ferric Gluconate ComplexAlso: IV Ferrlecit125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length. | Drug | Treatment |
Primary outcome
6-minute walk change at 1 month.
Time frame: 30 days.
6-minute walk change (meters) between baseline and 1 month follow-up.
6-minute walk change at one year.
Time frame: One year.
6-minute walk change (meters) between baseline and 1 year follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 41870899Bar O, Zukermann R, Halhal B, Marcusohn E. The effect of intravenous sodium ferric gluconate complex (Ferrlecit) on outcomes of patients undergoing transcatheter aortic valve implantation: a prospective randomized controlled trial. J Cardiovasc Med (Hagerstown). 2026 May 1;27(5):389-397. doi: 10.2459/JCM.0000000000001867. Epub 2026 Mar 17.
- 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
Cardiology Department, Rambam Health Care Campus,Haifa,Israel
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 Sodium Ferric Gluconate Complex in people with Iron Deficiency Anemia Due to Blood Loss and Aortic Stenosis, 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erez Marcusohn, MD (97247772180, e_marcusohn@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk change at 1 month. (time frame: 30 days.). The study lists 2 primary outcomes in all. 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 NCT04797832, 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 27 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.