Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/132504
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
Type: | Journal article |
Title: | Rationale and design of the IRON-AF study: a double-blind, randomised, placebo-controlled study to assess the effect of intravenous ferric carboxymaltose in patients with atrial fibrillation and iron deficiency |
Author: | Tu, S.J. Elliott, A.D. Hanna-Rivero, N. Gallagher, C. Mishima, R.S. Lyrtzis, E. Wlochowicz, D. Clarke, N.A. Roberts-Thomson, K.C. Stokes, M.B. Emami, M. Lau, D.H. Sanders, P. Wong, C.X. |
Citation: | BMJ Open, 2021; 11(8):e047642-1-e047642-7 |
Publisher: | BMJ Publishing Group |
Issue Date: | 2021 |
ISSN: | 2044-6055 2044-6055 |
Statement of Responsibility: | Samuel J Tu, Adrian D Elliott, Nicole Hanna-Rivero, Celine Gallagher, Ricardo S Mishima, Ellen Lyrtzis, Danielle Wlochowicz, Nicholas AR Clarke, Kurt C Roberts-Thomson, Michael B Stokes, Mehrdad Emami, Dennis H Lau, Prashanthan Sanders, Christopher X Wong |
Abstract: | Introduction: Atrial fibrillation (AF) is associated with significantly impaired quality-of-life. Iron deficiency (ID) is prevalent in patients with AF. Correction of ID in other patient populations with intravenous iron supplementation has been shown to be a safe, convenient and effective way of improving exercise tolerance, fatigue and quality-of-life. The IRON-AF (Effect of Iron Repletion in Atrial Fibrillation) study is designed to assess the effect of iron repletion with intravenous ferric carboxymaltose in patients with AF and ID. Methods and Analysis: The IRON-AF study is a double-blind, randomised controlled trial that will recruit at least 84 patients with AF and ID. Patients will be randomised to receive infusions of either ferric carboxymaltose or placebo, given in repletion and then maintenance doses. The study will have follow-up visits at weeks 4, 8 and 12. The primary endpoint is change in peak oxygen uptake from baseline to week 12, as measured by cardiopulmonary exercise testing (CPET) on a cycle ergometer. Secondary endpoints include changes in quality-of-life and AF disease burden scores, blood parameters, other CPET parameters, transthoracic echocardiogram parameters, 6-minute walk test distance, 7-day Holter/Event monitor burden of AF, health resource utilisation and mortality. Ethics and dissemination: The study protocol has been approved by the Central Adelaide Local Health Network Human Research Ethics Committee, Australia. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations. |
Keywords: | Atrial fibrilation; iron deficiency |
Rights: | © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
DOI: | 10.1136/bmjopen-2020-047642 |
Grant ID: | NHMRC |
Published version: | http://dx.doi.org/10.1136/bmjopen-2020-047642 |
Appears in Collections: | Medicine publications |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
hdl_132504.pdf | Published version | 580.15 kB | Adobe PDF | View/Open |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.