interventional
N/A
1 country
1
To determine whether intravenous iron (ferric carboxymaltose) would improve Quality of life and Exercise Capacity in patients with severe Aortic Stenosis and Iron Deficiency undergoing TAVI
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2023
Actual (reported)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).
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
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, 3015 GD, Netherlands
Dr RJ Nuis
First Submitted
October 2, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction
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