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Title: | Rationale and design of the IRON‐CRT trial: effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy | Authors: | Somers, Frauke Timmermans, Philippe VERWERFT, Jan DAUW, Jeroen MULLENS, Wilfried MARTENS, Pieter DUPONT, Matthias HERBOTS, Lieven |
Issue Date: | 2019 | Publisher: | WILEY PERIODICALS, INC | Source: | ESC HEART FAILURE, 6 (6) , p. 1208 -1215 | Abstract: | Aims Iron deficiency is common in heart failure with reduced ejection fraction (HFrEF). In patients with cardiac resynchronization therapy (CRT), it is associated with a diminished reverse remodelling response and poor functional improvement. The latter is partially related to a loss in contractile force at higher heart rates (negative force-frequency relationship). Methods and results The effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy (IRON-CRT) trial is a multicentre, prospective, randomized, double-blind controlled trial in HFrEF patients who experienced incomplete reverse remodelling (defined as a left ventricular ejection fraction below <45%) at least 6 months after CRT. Additionally, patients need to have iron deficiency defined as a ferritin below 100 mu g/L irrespective of transferrin saturation or a ferritin between 100 and 300 mu g/L with a transferrin saturation <20%. Patients will be randomized to either intravenous ferric carboxymaltose (dose based according to Summary of Product Characteristics) or intravenous placebo. The primary objective is to evaluate the effect of ferric carboxymaltose on metrics of cardiac reverse remodelling and contractility, measured by the primary endpoint, change in left ventricular ejection fraction assessed by three-dimensional (3D) echo from baseline to 3 month follow-up and the secondary endpoints change in left ventricular end-systolic and end-diastolic volume. The secondary objective is to determine if ferric carboxymaltose is capable of improving cardiac contractility in vivo, by assessing the force-frequency relationship through incremental biventricular pacing. A total of 100 patients will be randomized in a 1:1 fashion. Conclusions The IRON-CRT trial will determine the effect of ferric carboxymaltose on cardiac reverse remodelling and rate-dependent cardiac contractility in HFrEF patients. | Notes: | Martens, P (reprint author), Ziekenhuis Oost Limburg, Dept Cardiol, Schiepse Bos 6, B-3600 Genk, Belgium. pieter.martens2@zol.be |
Other: | Martens, P (reprint author), Ziekenhuis Oost Limburg, Dept Cardiol, Schiepse Bos 6, B-3600 Genk, Belgium. pieter.martens2@zol.be | Keywords: | Iron deficiency;Cardiac remodelling;Contractility;Heart failure | Document URI: | http://hdl.handle.net/1942/30687 | ISSN: | 2055-5822 | e-ISSN: | 2055-5822 | DOI: | 10.1002/ehf2.12503 | ISI #: | WOS:000509874700011 | Rights: | 2019 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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