IV Sodium Ferric Gluconate Complex in Patients Undergoing TAVI

• Status: Recruiting
• Trial end date: 2024-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Ferric gluconate

Criteria

• Inclusion criteria: (All criteria need to be met)

1. Patients admitted for TAVI.

2. Hb level 8-14 mg/dl on admission.

3. No evidence of active bleeding.

4. Patient provided informed consent.

5. The patient is able to walk without support for 6 minutes.

6. LVEF >= 45%

• Exclusion criteria:

1. Previous allergy or anaphylaxis due to IV Iron.

2. Active malignancy undergoing treatment.

3. Status post major surgery involving substantial blood loss in the past 3 months.

4. Infection indicating IV antibiotics, not including prophylaxis for TAVI.

5. History of acquired iron overload; known haemochromatosis or first relatives with hemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).

6. Hemolytic anemia.

7. 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.

8. Recipient of immunosuppressive therapy or renal dialysis. History of erythropoietin, IV iron therapy, and blood transfusion in previous 30 days.

9. Musculoskeletal limitation that, in the judgement of the investigator, would impair 6-minute walk.

10. Pregnant or breastfeeding.

11. Inability to comprehend study protocol.

12. Parallel participation in another clinical trial.

13. During TAVI or the day following the procedure:

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.