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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | 100 patients receiving IV Iron during index hospitalisation. |
|
| No treatment | No Intervention | 100 patients not receiving IV Iron above standout treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Sodium Ferric Gluconate Complex | Drug | 125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk change at 1 month. | 6-minute walk change (meters) between baseline and 1 month follow-up. | 30 days. |
| 6-minute walk change at one year. | 6-minute walk change (meters) between baseline and 1 year follow-up. | One year. |
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Inclusion criteria: (All criteria need to be met)
Exclusion criteria:
I. 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erez Marcusohn, MD | Contact | 97247772180 | e_marcusohn@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Erez Marcusohn, MD | Cardiology Department, Rambam Health Care Campus,Haifa,Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41870899 | Derived | 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. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
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Single blinded randomized control trial.
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The outcomes assessor is blinded to whether the patient received IV Iron.
| D014694 |
| Ventricular Outflow Obstruction |