Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Stenosis, Iron-deficiency

Intervention / Treatment
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* Drug: Ferric carboxymaltose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron supplementation<br>Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo) | Drug: Ferric carboxymaltose<br>* Intravenous ferric carboxymaltose according to baseline weight and hemoglobin<br>|
| Placebo Comparator: Placebo<br>Intravenous 0.9% NaCl (placebo) will be administered as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention | Drug: Ferric carboxymaltose<br>* Intravenous ferric carboxymaltose according to baseline weight and hemoglobin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with heart failure hospital admission or cardiovascular death | Analyzed as time-to-event | up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of allogeneic RBC units received |  | 30 days post-TAVI or SAVR | 
| Walking distance | 6 minute walking test | 6 months post-TAVI or SAVR | 
| Kansas City Cardiomyopathy Questionnaire | Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status. | 6 months post-TAVI or SAVR | 
| Patient Global Assessment | Patient reported outcome on the impact of the disease in daily live | 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. | 6 months post-TAVI or SAVR |