Status:
UNKNOWN
Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Lead Sponsor:
Hospital de Santa Cruz, Portugal
Conditions:
Aortic Stenosis
Iron-deficiency
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary ...
Eligibility Criteria
Inclusion
- Severe aortic stenosis
- Enrolled for TAVI or SAVR procedures
- Documented iron deficiency with either: Ferritin \<100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation \< 20%.
Exclusion
- Use of packed red blood cells or whole blood in the past 3 months;
- Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
- Use of oral or IV iron (\>100mg/day) in the past 3 months;
- Haemoglobin (Hb) levels \> 15g/dL or \< 8g/dL;
- Active cancer;
- Infection requiring antibiotic treatment at the time of first scheduled dose;
- Any known contraindication to study intervention
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT04786769
Start Date
January 1 2022
End Date
June 1 2025
Last Update
March 8 2021
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