NCT04786769

Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Hospital de Santa Cruz, Portugal · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2021-03-08
• Last updated: 2021-03-08