Clinical trial NCT04786769: Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Official title: A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Stenosis
Iron-deficiency
Lead sponsor: Hospital de Santa Cruz, Portugal
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of patients with heart failure hospital admission or cardiovascular death
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Total number of allogeneic RBC units received
timeFrame: 30 days post-TAVI or SAVR
measure: Walking distance
timeFrame: 6 months post-TAVI or SAVR
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 6 months post-TAVI or SAVR
measure: Patient Global Assessment
timeFrame: 6 months post-TAVI or SAVR
measure: EQ-5D-5L
timeFrame: 6 months post-TAVI or SAVR
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Santa Cruz, Portugal
name: Afonso Félix-Oliveira, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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