Aortic Valve StenosisPhase 4IRON TAVINCT07370688
Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation
A Phase 4 study testing Intravenous ferric carboxymaltose in people with Aortic Valve Stenosis and Iron Deficiency, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Iron Deficiency, TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- Intravenous ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Aug 2024to Jul 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015 GD
Rutger-Jan Nuis, MD, PhD, +31614858291, r.nuis@erasmusmc.nl
About this study
Official title: Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial
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:
Read more
- Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?
- 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:
- Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)
- 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)
- Conditions
- Aortic Valve Stenosis, Iron Deficiency, TAVI(Transcatheter Aortic Valve Implantation), Cardiovascular Diseases
- Being tested
- Intravenous ferric carboxymaltose
- Keywords
- Health-related Quality of Life, Six-Minute Walk Test, Randomized Controlled Trial, Aortic Valve Stenosis, Intravenous Iron Therapy, Kansas City Cardiomyopathy Questionnaire, Functional Recovery, Iron Deficiency, Cardiovascular Diseases
- Medical subject headings
- Aortic Valve Stenosis, Iron Deficiencies, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ferric carboxymaltoseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Receiving intravenous iron therapy (ferric carboxymaltose) after TAVI, administered in 1-3 settings over the course of 12 weeks. Receives: Drug: Intravenous ferric carboxymaltose |
| Control arm | No intervention | Receiving standard of care, i.e. no intravenous iron therapy (ferric carboxymaltose) after TAVI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-related Quality of Life (HRQOL)
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.
Measured: 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.
Change in 6-Minute Walk Test (6-MWT)
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.
Measured: 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.
Secondary outcomes (7)
Cognitive function (MMSE)
Cognitive function using the Mini Mental State Examination (MMSE)
Measured: Measured at week-24 post-TAVI
New York Heart Association (NYHA) functional class
Measured: Measured at week-24 post-TAVI
European Quality of Life-5 Dimensions 5 Level Utility Index (EQ-5D-5L-UI) and Visual Analog Scale (EQ-5D-VAS)
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.
Measured: Measured at week-24 post-TAVI
Composite of cardiovascular mortality and heart failure hospitalizations
Measured: Measured at week-24 post-TAVI
All-cause mortality
Measured: Measured at week-24 post-TAVI
Favourable quality of life (QoL)
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)
Measured: Measured at baseline (pre-TAVI) and week-24 post-TAVI
Patient Global Assessment
Measured: Measured at week-24 post-TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start12 Aug 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rutger-Jan Nuis, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370688
- Sponsor's protocol ID
- MEC-2024-0152
- Acronym
- IRON TAVI
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No