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NCT Number: NCT07370688

Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI).

The main questions it aims to answer are:

1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)? 2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?

The intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).

Participants will:

* Provide written informed consent * Be randomly assigned to one of two groups:

1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks) 2. Control group: receiving standard of care (= no iron therapy) * Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI. * During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases TAVI(Transcatheter Aortic Valve Implantation) Ventricular Outflow Obstruction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Rutger-Jan Nuis, MD, PhD

CONTACT

[email protected]

+31614858291

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age ≥ 65 years
  • Patients with severe AS and ID undergoing successful TAVI
  • ID defined as Ferritin < 100 ug/L and/or Transferrin saturation < 20%
  • Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)
  • Signed Informed Consent

Exclusion criteria

  • Contra-indication for TAVI
  • Ferritin > 400 ug/L
  • Hemoglobin <5.6 mmol/L or <9 g/dL
  • Hemoglobin >8.7 mmol/L or >14 g/dL in men and >8.1 mmol/L or >13 g/dL in women
  • Anaemia due to known reasons other than ID and/or anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)
  • Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
  • Renal dialysis (previous, current, or planned within the next 6 months) or MDRD/CKD-EPI estimated glomerular filtration rate <15 mL/min.
  • History of iron overload
  • History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and/or such therapy planned within next 6 months
  • Clinically apparent infection requiring antibiotic treatment
  • Known hypersensitivity to iFCM or to any of its excipients
  • Pregnancy
  • Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and/or quality of life assessment.

Treatment and study plan

Intravenous ferric carboxymaltose

Drug

The intervention involves the administration of intravenous ferric carboxymaltose (FCM) to correct iron deficiency (ID) in patients with severe aortic stenosis. FCM will be delivered in 1 to 3 settings, depending on the patient's baseline hemoglobin level, body weight, and persistence of ID after the initial administration(s):

  • Setting-1: After successful TAVI and before hospital discharge, a maximum of 1000 milligrams of FCM will be administered.
  • Setting-2: A second dose of 500-1000 milligrams FCM will be administered during outpatient-clinic visit if the cumulative iron dosage has not yet been met.
  • Setting-3: A third dose of 500 milligrams of FCM will be administered at week 12 if ID recurs or persists during follow-up.

Each dose will be infused using peripheral venous access over at least 15 minutes. The total duration of the intervention is 12 weeks, after which an endpoint outpatient follow-up assessment takes place at week 24 post-TAVI.

Primary outcomes

  1. Change in Health-related Quality of Life (HRQOL)

    Time frame: The KCCQ-23 will be filled out pre-TAVI during an outpatient or inpatient geriatric visit, or at home and will be filled out again at week-24 post-TAVI during outpatient visit or at home.

    The primary endpoint is the change in HRQOL from baseline (pre-TAVI) to week-24 using the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) which has been validated in patients undergoing TAVI.

  2. Change in 6-Minute Walk Test (6-MWT)

    Time frame: 6-MWT is performed pre-TAVI during an outpatient or inpatient geriatric visit and will be measured again at week-24 post-TAVI during outpatient visit.

    The co-primary endpoint is change in exercise capacity from baseline (pre-TAVI) to week-24 using the 6-MWT, which is an established objective means of evaluation exercise capacity in the TAVI population.

Secondary outcomes

  1. Cognitive function (MMSE)

    Time frame: Measured at week-24 post-TAVI

    Cognitive function using the Mini Mental State Examination (MMSE)

  2. New York Heart Association (NYHA) functional class

    Time frame: Measured at week-24 post-TAVI

  3. European Quality of Life-5 Dimensions 5 Level Utility Index (EQ-5D-5L-UI) and Visual Analog Scale (EQ-5D-VAS)

    Time frame: Measured at week-24 post-TAVI

    EQ5D comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (no, slight, moderate, severe, and extreme problems) by which a unique health state per item is determined. These health states are converted into weighted health states (Utility Index or EQ-5D-5L-UI) by applying scores on which full health has a value of 1 and death a value of 0. The Visual Analog Scale (EQ-5D-VAS) is a self-reported score ranging from 0-100 with higher scores indicating better health.

  4. Composite of cardiovascular mortality and heart failure hospitalizations

    Time frame: Measured at week-24 post-TAVI

  5. All-cause mortality

    Time frame: Measured at week-24 post-TAVI

  6. Favourable quality of life (QoL)

    Time frame: Measured at baseline (pre-TAVI) and week-24 post-TAVI

    Favourable QoL is defined as survival with a KCCQ-score ≥60 without KCCQ-decline >10 points from baseline to follow-up (week-24 post-TAVI)

  7. Patient Global Assessment

    Time frame: Measured at week-24 post-TAVI

Study contacts

Contact information is provided by the study sponsor or research team.

Rutger-Jan Nuis, MD, PhD

CONTACT

[email protected]

+31614858291

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial

Acronym: IRON TAVI

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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