Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation

Официальное название

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

Обзор

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)

Вмешательства

• Препарат 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

Первичные конечные точки

• Change in Health-related Quality of Life (HRQOL) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Erasmus University Medical Center — Rotterdam

Идентификаторы

NCT: NCT07370688 · MEC-2024-0152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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