IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI

Phase 4

Recruiting

• Conditions: Iron Deficiency Anemia Due to Blood Loss; Aortic Stenosis
• Interventions: Drug: IV Sodium Ferric Gluconate Complex

• Registration Number: NCT04797832
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study Start: 2020-10-18
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	IV Sodium Ferric Gluconate Complex	100 patients receiving IV Iron during index hospitalisation.

Primary Outcome Measures

Name	Time	Method
6-minute walk change at 1 month.	30 days.	6-minute walk change (meters) between baseline and 1 month follow-up.
6-minute walk change at one year.	One year.	6-minute walk change (meters) between baseline and 1 year follow-up.

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel