Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial

Background Intravenous ferric carboxymaltose (FCM) improves symptoms, functional capacity, and quality of life in heart failure and iron deficiency. The mechanisms underlying these effects are not fully understood. The aim of this study was to examine changes in myocardial iron content after FCM adm...

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Main Authors: Julio Núñez, Gema Miñana, Ingrid Cardells, Patricia Palau, Pau Llàcer, Lorenzo Fácila, Luis Almenar, Maria P. López‐Lereu, Jose V. Monmeneu, Martina Amiguet, Jessika González, Alicia Serrano, Vicente Montagud, Raquel López‐Vilella, Ernesto Valero, Sergio García‐Blas, Vicent Bodí, Rafael de la Espriella‐Juan, Josep Lupón, Jorge Navarro, José Luis Górriz, Juan Sanchis, Francisco J. Chorro, Josep Comín‐Colet, Antoni Bayés‐Genís
Format: Article
Language:English
Published: Wiley 2020-02-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
Online Access:https://www.ahajournals.org/doi/10.1161/JAHA.119.014254
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author Julio Núñez
Gema Miñana
Ingrid Cardells
Patricia Palau
Pau Llàcer
Lorenzo Fácila
Luis Almenar
Maria P. López‐Lereu
Jose V. Monmeneu
Martina Amiguet
Jessika González
Alicia Serrano
Vicente Montagud
Raquel López‐Vilella
Ernesto Valero
Sergio García‐Blas
Vicent Bodí
Rafael de la Espriella‐Juan
Josep Lupón
Jorge Navarro
José Luis Górriz
Juan Sanchis
Francisco J. Chorro
Josep Comín‐Colet
Antoni Bayés‐Genís
author_facet Julio Núñez
Gema Miñana
Ingrid Cardells
Patricia Palau
Pau Llàcer
Lorenzo Fácila
Luis Almenar
Maria P. López‐Lereu
Jose V. Monmeneu
Martina Amiguet
Jessika González
Alicia Serrano
Vicente Montagud
Raquel López‐Vilella
Ernesto Valero
Sergio García‐Blas
Vicent Bodí
Rafael de la Espriella‐Juan
Josep Lupón
Jorge Navarro
José Luis Górriz
Juan Sanchis
Francisco J. Chorro
Josep Comín‐Colet
Antoni Bayés‐Genís
author_sort Julio Núñez
collection DOAJ
description Background Intravenous ferric carboxymaltose (FCM) improves symptoms, functional capacity, and quality of life in heart failure and iron deficiency. The mechanisms underlying these effects are not fully understood. The aim of this study was to examine changes in myocardial iron content after FCM administration in patients with heart failure and iron deficiency using cardiac magnetic resonance. Methods and Results Fifty‐three stable heart failure and iron deficiency patients were randomly assigned 1:1 to receive intravenous FCM or placebo in a multicenter, double‐blind study. T2* and T1 mapping cardiac magnetic resonance sequences, noninvasive surrogates of intramyocardial iron, were evaluated before and 7 and 30 days after randomization using linear mixed regression analysis. Results are presented as least‐square means with 95% CI. The primary end point was the change in T2* and T1 mapping at 7 and 30 days. Median age was 73 (65–78) years, with N‐terminal pro‐B‐type natriuretic peptide, ferritin, and transferrin saturation medians of 1690 pg/mL (1010–2828), 63 ng/mL (22–114), and 15.7% (11.0–19.2), respectively. Baseline T2* and T1 mapping values did not significantly differ across treatment arms. On day 7, both T2* and T1 mapping (ms) were significantly lower in the FCM arm (36.6 [34.6–38.7] versus 40 [38–42.1], P=0.025; 1061 [1051–1072] versus 1085 [1074–1095], P=0.001, respectively). A similar reduction was found at 30 days for T2* (36.3 [34.1–38.5] versus 41.1 [38.9–43.4], P=0.003), but not for T1 mapping (1075 [1065–1085] versus 1079 [1069–1089], P=0.577). Conclusions In patients with heart failure and iron deficiency, FCM administration was associated with changes in the T2* and T1 mapping cardiac magnetic resonance sequences, indicative of myocardial iron repletion. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03398681.
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spelling doaj.art-e1e8273a4ca540c59dcf92120389f24a2023-03-13T05:25:33ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802020-02-019410.1161/JAHA.119.014254Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON TrialJulio Núñez0Gema Miñana1Ingrid Cardells2Patricia Palau3Pau Llàcer4Lorenzo Fácila5Luis Almenar6Maria P. López‐Lereu7Jose V. Monmeneu8Martina Amiguet9Jessika González10Alicia Serrano11Vicente Montagud12Raquel López‐Vilella13Ernesto Valero14Sergio García‐Blas15Vicent Bodí16Rafael de la Espriella‐Juan17Josep Lupón18Jorge Navarro19José Luis Górriz20Juan Sanchis21Francisco J. Chorro22Josep Comín‐Colet23Antoni Bayés‐Genís24Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital General de Castellón Universitat Jaume I Castellón SpainInternal Medicine Department Hospital de Manises Manises SpainCardiology Department Hospital General Universitario de Valencia Valencia SpainCardiology Department Hospital Universitario La Fe de Valencia Valencia SpainUnidad de Imagen Cardiaca (ERESA) Hospital Clínico Universitario de Valencia Valencia SpainUnidad de Imagen Cardiaca (ERESA) Hospital Clínico Universitario de Valencia Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital General de Castellón Universitat Jaume I Castellón SpainCardiology Department Hospital General Universitario de Valencia Valencia SpainCardiology Department Hospital Universitario La Fe de Valencia Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCIBER Cardiovascular Universitat Jaume I Castellón SpainHospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainNephrology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainCardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia SpainDepartment of Cardiology Hospital del Mar Barcelona SpainCIBER Cardiovascular Universitat Jaume I Castellón SpainBackground Intravenous ferric carboxymaltose (FCM) improves symptoms, functional capacity, and quality of life in heart failure and iron deficiency. The mechanisms underlying these effects are not fully understood. The aim of this study was to examine changes in myocardial iron content after FCM administration in patients with heart failure and iron deficiency using cardiac magnetic resonance. Methods and Results Fifty‐three stable heart failure and iron deficiency patients were randomly assigned 1:1 to receive intravenous FCM or placebo in a multicenter, double‐blind study. T2* and T1 mapping cardiac magnetic resonance sequences, noninvasive surrogates of intramyocardial iron, were evaluated before and 7 and 30 days after randomization using linear mixed regression analysis. Results are presented as least‐square means with 95% CI. The primary end point was the change in T2* and T1 mapping at 7 and 30 days. Median age was 73 (65–78) years, with N‐terminal pro‐B‐type natriuretic peptide, ferritin, and transferrin saturation medians of 1690 pg/mL (1010–2828), 63 ng/mL (22–114), and 15.7% (11.0–19.2), respectively. Baseline T2* and T1 mapping values did not significantly differ across treatment arms. On day 7, both T2* and T1 mapping (ms) were significantly lower in the FCM arm (36.6 [34.6–38.7] versus 40 [38–42.1], P=0.025; 1061 [1051–1072] versus 1085 [1074–1095], P=0.001, respectively). A similar reduction was found at 30 days for T2* (36.3 [34.1–38.5] versus 41.1 [38.9–43.4], P=0.003), but not for T1 mapping (1075 [1065–1085] versus 1079 [1069–1089], P=0.577). Conclusions In patients with heart failure and iron deficiency, FCM administration was associated with changes in the T2* and T1 mapping cardiac magnetic resonance sequences, indicative of myocardial iron repletion. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03398681.https://www.ahajournals.org/doi/10.1161/JAHA.119.014254cardiac magnetic resonanceferric carboxymaltoseheart failureiron deficiencymyocardial iron
spellingShingle Julio Núñez
Gema Miñana
Ingrid Cardells
Patricia Palau
Pau Llàcer
Lorenzo Fácila
Luis Almenar
Maria P. López‐Lereu
Jose V. Monmeneu
Martina Amiguet
Jessika González
Alicia Serrano
Vicente Montagud
Raquel López‐Vilella
Ernesto Valero
Sergio García‐Blas
Vicent Bodí
Rafael de la Espriella‐Juan
Josep Lupón
Jorge Navarro
José Luis Górriz
Juan Sanchis
Francisco J. Chorro
Josep Comín‐Colet
Antoni Bayés‐Genís
Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
cardiac magnetic resonance
ferric carboxymaltose
heart failure
iron deficiency
myocardial iron
title Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
title_full Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
title_fullStr Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
title_full_unstemmed Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
title_short Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial‐IRON Trial
title_sort noninvasive imaging estimation of myocardial iron repletion following administration of intravenous iron the myocardial iron trial
topic cardiac magnetic resonance
ferric carboxymaltose
heart failure
iron deficiency
myocardial iron
url https://www.ahajournals.org/doi/10.1161/JAHA.119.014254
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