Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

NCT07370688 | Recruiting Phase 4 DMC

• 1 other identifier: MEC-2024-0152
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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 implantation (TAVI). The main questions it aims to answer are:

• 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

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Measured at week-24 post-TAVI

• New York Heart Association (NYHA) functional class

  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)

  Measured at week-24 post-TAVI

• Composite of cardiovascular mortality and heart failure hospitalizations

  Measured at week-24 post-TAVI

• All-cause mortality

  Measured at week-24 post-TAVI

Study Arms (2)

Intervention arm

EXPERIMENTAL

Receiving intravenous iron therapy (ferric carboxymaltose) after TAVI, administered in 1-3 settings over the course of 12 weeks.

Drug: Intravenous ferric carboxymaltose

Control arm

NO INTERVENTION

Receiving standard of care, i.e. no intravenous iron therapy (ferric carboxymaltose) after TAVI.

Interventions

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): 1. Setting-1: After successful TAVI and before hospital discharge, a maximum of 1000 milligrams of FCM will be administered. 2. 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. 3. 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.

Intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Iron Deficiencies; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Rutger-Jan Nuis, MD, PhD

CONTACT

+31614858291; r.nuis@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: August 12, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

NL (1)