Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

Official title

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

Overview

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)

Interventions

• Drug Intravenous ferric carboxymaltose
  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 milli

Primary outcome measures

• 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.]
• 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.]

Secondary outcome measures (7)

• Cognitive function (MMSE) [Time frame: Measured at week-24 post-TAVI]
• New York Heart Association (NYHA) functional class [Time frame: 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) [Time frame: Measured at week-24 post-TAVI]
• Composite of cardiovascular mortality and heart failure hospitalizations [Time frame: Measured at week-24 post-TAVI]
• All-cause mortality [Time frame: Measured at week-24 post-TAVI]
• Favourable quality of life (QoL) [Time frame: Measured at baseline (pre-TAVI) and week-24 post-TAVI]
• Patient Global Assessment [Time frame: Measured at week-24 post-TAVI]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Erasmus University Medical Center — Rotterdam

Identifiers

NCT: NCT07370688 · MEC-2024-0152

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗