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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,500
Intravenous ferric carboxymaltose according to baseline weight and hemoglobin
Number of patients with heart failure hospital admission or cardiovascular death
Analyzed as time-to-event
Time frame: up to 52 weeks
Total number of allogeneic RBC units received
Time frame: 30 days post-TAVI or SAVR
Walking distance
6 minute walking test
Time frame: 6 months post-TAVI or SAVR
Kansas City Cardiomyopathy Questionnaire
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Time frame: 6 months post-TAVI or SAVR
Patient Global Assessment
Patient reported outcome on the impact of the disease in daily live
Time frame: 6 months post-TAVI or SAVR
EQ-5D-5L
Quality of life assessment in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: 6 months post-TAVI or SAVR
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