Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Phase 4

Not yet recruiting

• Conditions: Aortic Stenosis; Iron-deficiency
• Interventions: Drug: Ferric carboxymaltose

• Registration Number: NCT04786769
• Lead Sponsor: Hospital de Santa Cruz, Portugal

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08
• Study Start: 2022-01
• Primary Completion: 2025-01
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron supplementation	Ferric carboxymaltose	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)
Placebo	Ferric carboxymaltose	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

Primary Outcome Measures

Name	Time	Method
Number of patients with heart failure hospital admission or cardiovascular death	up to 52 weeks	Analyzed as time-to-event

Secondary Outcome Measures

Name	Time	Method
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.
Total number of allogeneic RBC units received	30 days post-TAVI or SAVR
Kansas City Cardiomyopathy Questionnaire	6 months post-TAVI or SAVR	Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Walking distance	6 months post-TAVI or SAVR	6 minute walking test