Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Change in Health-related Quality of Life (HRQOL)
研究概览
简要总结
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:
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention arm
Receiving intravenous iron therapy (ferric carboxymaltose) after TAVI, administered in 1-3 settings over the course of 12 weeks.
干预措施: Intravenous ferric carboxymaltose (Drug)
Control arm
Receiving standard of care, i.e. no intravenous iron therapy (ferric carboxymaltose) after TAVI.
结局指标
主要结局
Change in Health-related Quality of Life (HRQOL)
时间窗: 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.
Change in 6-Minute Walk Test (6-MWT)
时间窗: 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.
次要结局
- 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)
- Favourable quality of life (QoL)(Measured at baseline (pre-TAVI) and week-24 post-TAVI)
- Patient Global Assessment(Measured at week-24 post-TAVI)
研究者
Rutger-Jan Nuis
MD, PhD
Erasmus Medical Center