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September 28, 2019ESC Heart FailureOpen Access

Rationale and Design of the IRON-CRT Trial: Effect of Intravenous Ferric Carboxymaltose on Reverse Remodelling Following Cardiac Resynchronization Therapy

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Why the study?

In HFrEF patients with CRT, iron deficiency is associated with diminished reverse remodelling and poor functional improvement, partially related to impaired contractile force at higher heart rates.

Does intravenous ferric carboxymaltose improve left ventricular ejection fraction in HFrEF patients with incomplete reverse remodelling after CRT and iron deficiency?

Population

100 HFrEF patients with iron deficiency and incomplete reverse remodelling after CRT

Comparison

Intravenous ferric carboxymaltose vs intravenous placebo

Design

Multicentre prospective randomized double-blind controlled trial

Follow-up

3 month

Authors

PMPieter MartensMDMatthias DupontJDJeroen Dauw

Discussion

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Overview

Tests IV iron for remodelling in iron-deficient HFrEF with incomplete CRT response; RCT will extend evidence on iron repletion.

Structured PICO

Does intravenous ferric carboxymaltose improve left ventricular ejection fraction in HFrEF patients with incomplete reverse remodelling after CRT and iron deficiency?

P
Population
100 HFrEF patients who experienced incomplete reverse remodelling (LVEF <45%) at least 6 months after CRT, with iron deficiency (ferritin <100 μg/L or ferritin 100-300 μg/L with TSAT <20%)
I
Intervention
Intravenous ferric carboxymaltose (dose based according to Summary of Product Characteristics)
C
Comparator
Intravenous placebo
O
Outcome
Change in left ventricular ejection fraction assessed by three-dimensional (3D) echo from baseline to 3 month follow-upsurrogate

The IRON-CRT trial is designed to evaluate whether intravenous ferric carboxymaltose improves cardiac reverse remodelling and contractility in HFrEF patients with iron deficiency and an incomplete response to CRT.

Cite This Study

Martens et al. (2019) studied this question.

synapsesocial.com/papers/6a1bf6741567d2fc4d5f5577https://doi.org/10.1002/ehf2.12503
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