{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T09:08:40Z","timestamp":1765012120510,"version":"3.46.0"},"reference-count":42,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T00:00:00Z","timestamp":1662076800000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pharmacosmos A\/S","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,7,13]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Iron 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\n                      <jats:italic>I<\/jats:italic>\n                      ntravenous\n                      <jats:italic>I<\/jats:italic>\n                      ron Supplement for\n                      <jats:italic>I<\/jats:italic>\n                      ron Deficiency in Patients with\n                      <jats:italic>S<\/jats:italic>\n                      evere\n                      <jats:italic>A<\/jats:italic>\n                      ortic\n                      <jats:italic>S<\/jats:italic>\n                      tenosis (IIISAS) trial, we aim to examine whether a single administration of ferric derisomaltose can improve physical capacity after TAVI.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This 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\u2009months prior to TAVI, and the patients are followed for 3\u2009months after TAVI. Inclusion criteria are iron deficiency, defined as serum ferritin&lt;100\u2009\u00b5g\/L or ferritin between 100 and 300 \u00b5g\/L in combination with a transferrin saturation&lt;20% and written informed consent. Exclusion criteria include haemoglobin&lt;10\u2009g\/dL, red blood cell disorders, end-stage kidney failure, intolerance to ferric derisomaltose, and ongoing infections. The primary endpoint is the baseline-adjusted distance walked on a 6\u2009min walk test (6MWT) 3\u2009months after TAVI. Secondary end points include quality of life, New York Heart Association functional class (NYHA functional class), and skeletal muscle strength.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was obtained from the Regional Committee for Medical and Health Research of South-Eastern Norway and The Norwegian Medicines Agency. Enrolment has begun, and results are expected in 2022. The results of the IIISAS trial will be disseminated by presentations at international and national conferences and by publications in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04206228\">NCT04206228<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-059546","type":"journal-article","created":{"date-parts":[[2022,9,2]],"date-time":"2022-09-02T11:05:51Z","timestamp":1662116751000},"page":"e059546","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["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"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04206228","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Sara","family":"Bardan","sequence":"first","affiliation":[{"name":"Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9923-2685","authenticated-orcid":false,"given":"Anette Borger","family":"Kvaslerud","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway"},{"name":"Department of Cardiology, Rikshospitalet, Oslo University Hospital, Oslo, Norway"},{"name":"K.G. 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