Open AccessChanges in myocardial iron content following administration of intravenous iron (Myocardial‐IRON): Study design
Author(s) -
Miñana Gema,
Cardells Ingrid,
Palau Patricia,
Llàcer Pau,
Fácila Lorenzo,
Almenar Luis,
LópezLereu Maria Pilar,
Monmeneu Jose V.,
Amiguet Martina,
González Jessika,
Serrano Alicia,
Montagud Vicente,
LópezVilella Raquel,
Valero Ernesto,
GarcíaBlas Sergio,
Bodí Vicent,
de la EspriellaJuan Rafael,
Sanchis Juan,
Chorro Francisco J.,
BayésGenís Antoni,
Núñez Julio
Publication year - 2018
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.22956
Subject(s) - medicine , heart failure , ejection fraction , iron deficiency , placebo , clinical endpoint , cardiology , cardiac function curve , intravenous iron , randomized controlled trial , anemia , pathology , alternative medicine
Treatment with intravenous ferric carboxymaltose (FCM) has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure and iron deficiency. However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance changes in myocardial iron content after administration of intravenous FCM in patients with heart failure and iron deficiency and contrast them with parameters of heart failure severity. This is a multicenter, double-blind, randomized study. Fifty patients with stable symptomatic heart failure, left ventricular ejection fraction <50%, and iron deficiency will be randomly assigned 1:1 to receive intravenous FCM or placebo. Intramyocardial iron will be evaluated by T2* and T1 mapping cardiac magnetic resonance sequences before and at 7 and 30 days after FCM. After 30 days, patients assigned to placebo will receive intravenous FCM in case of persistent iron deficiency. The main endpoint will be changes from baseline in myocardial iron content at 7 and 30 days. Secondary endpoints will include the correlation of these changes with left ventricular ejection fraction, functional capacity, quality of life, and cardiac biomarkers. The results of this study will add important knowledge about the effects of intravenous FCM on myocardial tissue and cardiac function. We hypothesize that short-term (7 and 30 days) myocardial iron content changes after intravenous FCM, evaluated by cardiac magnetic resonance, will correlate with simultaneous changes in parameters of heart failure severity. The study is registered at http://www.clinicaltrials.gov (NCT03398681).