Rationale and design of the IRON‐CRT trial: effect of intravenous ferric carboxymaltose on reverse remodelling following cardiac resynchronization therapy

ESC heart failure - Tập 6 Số 6 - Trang 1208-1215 - 2019
Pieter Martens1,2, Matthias Dupont1, Jeroen Dauw1, Frauke Somers1, Lieven Herbots3, Philippe Timmermans3, Jan Verwerft3, Wilfried Mullens4,1
1Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium
2Doctoral School for Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium
3Department of Cardiology Jessa Ziekenhuis Hasselt Belgium
4Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium

Tóm tắt

AbstractAimsIron 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 resultsThe 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 μg/L irrespective of transferrin saturation or a ferritin between 100 and 300 μg/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.ConclusionsThe IRON‐CRT trial will determine the effect of ferric carboxymaltose on cardiac reverse remodelling and rate‐dependent cardiac contractility in HFrEF patients.

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ESC heart failure

Tập 6 Số 6

1208-1215

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