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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
Hospital de Santa Cruz, Portugal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    March 2, 2021
    Last Updated
    March 4, 2021
    Sponsor
    Hospital de Santa Cruz, Portugal
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    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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