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Iron Infusion in Elderly Patients undergoing Transcatheter Aortic Valve Implantation (IRON TAVI) Trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505095-29-03
Enrollment
378
Registered
2023-12-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Aortic stenosis and Iron deficiency

Brief summary

Quality of life at 6 months (using the 23-item Kansas City Cardiomyopathy Questionnaire, KCCQ-23, as continuous variable), Exercise capacity at 6 months (using 6-minute walk test, 6-MWT as continuous variable).

Detailed description

Cognitive function at 6 months (using the Mini Mental State Examination, MMSE as continuous variable)., NYHA classification at 6 months (as continuous variable)., Patient Global Assessment at 6 months (as continuous variable)., European Quality of Life-5 Dimensions Utility Index (EQ-5D-UI) and Visual Analog Scale (EQ-5D-VAS) at 6 months (as continuous variable)., Composite of cardiovascular mortality and heart failure hospitalizations at 6 months, All-cause mortality at 6 months, Favourable quality of life (survival with KCCQ-score ≥60 without KCCQ-decline >10 points from baseline to follow-up) at 6 months

Interventions

DRUGFerinject

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Quality of life at 6 months (using the 23-item Kansas City Cardiomyopathy Questionnaire, KCCQ-23, as continuous variable), Exercise capacity at 6 months (using 6-minute walk test, 6-MWT as continuous variable).—

Secondary

MeasureTime frame
Cognitive function at 6 months (using the Mini Mental State Examination, MMSE as continuous variable)., NYHA classification at 6 months (as continuous variable)., Patient Global Assessment at 6 months (as continuous variable)., European Quality of Life-5 Dimensions Utility Index (EQ-5D-UI) and Visual Analog Scale (EQ-5D-VAS) at 6 months (as continuous variable)., Composite of cardiovascular mortality and heart failure hospitalizations at 6 months, All-cause mortality at 6 months, Favourable quality of life (survival with KCCQ-score ≥60 without KCCQ-decline >10 points from baseline to follow-up) at 6 months—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026