Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency (INERTIA)

Hospital de Santa Cruz, Portugal

Status and phase: Not yet enrolling; Phase 4

Conditions: Iron-deficiency; Aortic Stenosis

Treatments: Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT04786769

UNICARV-1

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,500 participants in 2 patient groups, including a placebo group

Iron supplementation

Experimental group

Description:

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)

Treatment:

Drug: Ferric carboxymaltose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Ferric carboxymaltose