Aortic Stenosis, Iron-deficiency
Conditions
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 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.
Interventions
DRUGFerric carboxymaltose
Intravenous ferric carboxymaltose according to baseline weight and hemoglobin
Sponsors
Hospital de Santa Cruz, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with heart failure hospital admission or cardiovascular death | up to 52 weeks | Analyzed as time-to-event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of allogeneic RBC units received | 30 days post-TAVI or SAVR | — |
| Walking distance | 6 months post-TAVI or SAVR | 6 minute walking test |
| Kansas City Cardiomyopathy Questionnaire | 6 months post-TAVI or SAVR | Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status. |
| Patient Global Assessment | 6 months post-TAVI or SAVR | Patient reported outcome on the impact of the disease in daily live |
| EQ-5D-5L | 6 months post-TAVI or SAVR | 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. |
Contacts
Primary ContactAfonso Félix-Oliveira, MSc
Outcome results
None listed