Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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 endpoint is the time to HF hospital admission or cardiovascular death. Secondary endpoints will assess quality of life indicators and functional capacity at 6 months.

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

Details

• Lead Sponsor: Hospital de Santa Cruz, Portugal

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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