Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency (INERTIA)
Primary Purpose
Aortic Stenosis, Iron-deficiency
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Iron supplementation
Placebo
Arm 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)
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
Outcomes
Primary Outcome Measures
Number of patients with heart failure hospital admission or cardiovascular death
Analyzed as time-to-event
Secondary Outcome Measures
Total number of allogeneic RBC units received
Walking distance
6 minute walking test
Kansas City Cardiomyopathy Questionnaire
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Patient Global Assessment
Patient reported outcome on the impact of the disease in daily live
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.
Full Information
NCT ID
NCT04786769
First Posted
March 2, 2021
Last Updated
March 4, 2021
Sponsor
Hospital de Santa Cruz, Portugal
1. Study Identification
Unique Protocol Identification Number
NCT04786769
Brief Title
Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Acronym
INERTIA
Official Title
A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Santa Cruz, Portugal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Iron-deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iron supplementation
Arm Type
Experimental
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Intervention Description
Intravenous ferric carboxymaltose according to baseline weight and hemoglobin
Primary Outcome Measure Information:
Title
Number of patients with heart failure hospital admission or cardiovascular death
Description
Analyzed as time-to-event
Time Frame
up to 52 weeks
Secondary Outcome Measure Information:
Title
Total number of allogeneic RBC units received
Time Frame
30 days post-TAVI or SAVR
Title
Walking distance
Description
6 minute walking test
Time Frame
6 months post-TAVI or SAVR
Title
Kansas City Cardiomyopathy Questionnaire
Description
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Time Frame
6 months post-TAVI or SAVR
Title
Patient Global Assessment
Description
Patient reported outcome on the impact of the disease in daily live
Time Frame
6 months post-TAVI or SAVR
Title
EQ-5D-5L
Description
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.
Time Frame
6 months post-TAVI or SAVR
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afonso Félix-Oliveira, MSc
Phone
00351210433001
Email
afonso.felix.oliveira@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afonso Félix-Oliveira, MSc
Organizational Affiliation
Hospital de Santa Cruz, Portugal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency
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