Intravenous ferric derisomaltose in iron-deficient patients undergoing transcatheter aortic valve implantation due to severe aortic stenosis: study protocol of the randomised controlled IIISAS trial

IntroductionIron deficiency is a prevalent comorbidity in patients with severe aortic stenosis and may be associated with procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI). In the Intravenous Iron Supplement for Iron Deficiency in Patients with Severe Aortic Steno...

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Bibliographic Details
Published in:BMJ open 2022-09, Vol.12 (9), p.e059546-e059546
Main Authors: Bardan, Sara, Kvaslerud, Anette Borger, Andresen, Kristoffer, Kløve, Sophie Foss, Edvardsen, Thor, Gullestad, Lars, Broch, Kaspar
Format: Article
Language:English
Subjects:
Adult cardiology
Anemia
Aortic stenosis
Aortic Valve Stenosis - surgery
Cardiovascular disease
Cardiovascular Medicine
Chronic illnesses
Clinical outcomes
Clinical trials
Double-blind studies
Ejection fraction
Ferritins
Heart failure
Hospitalization
Humans
Inflammation
Iron
Iron Deficiencies
Mortality
Older people
Other metabolic, e.g. iron, porphyria
Quality of Life
Randomized Controlled Trials as Topic
Transcatheter Aortic Valve Replacement
Transplants & implants
Treatment Outcome
Valvular heart disease
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Summary:IntroductionIron deficiency is a prevalent comorbidity in patients with severe aortic stenosis and may be associated with procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI). In the Intravenous Iron Supplement for Iron Deficiency in Patients with Severe Aortic Stenosis (IIISAS) trial, we aim to examine whether a single administration of ferric derisomaltose can improve physical capacity after TAVI.Methods and analysisThis randomised, double-blind, placebo-controlled trial aims to enrol 150 patients with iron deficiency who are scheduled for TAVI due to severe aortic stenosis. The study drug and matching placebo are administered approximately 3 months prior to TAVI, and the patients are followed for 3 months after TAVI. Inclusion criteria are iron deficiency, defined as serum ferritin
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-059546