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...
Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1827992582135742464 |
---|---|
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. |
first_indexed | 2024-04-10T04:06:20Z |
format | Article |
id | doaj.art-e1e8273a4ca540c59dcf92120389f24a |
institution | Directory Open Access Journal |
issn | 2047-9980 |
language | English |
last_indexed | 2024-04-10T04:06:20Z |
publishDate | 2020-02-01 |
publisher | Wiley |
record_format | Article |
series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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 |
work_keys_str_mv | AT julionunez noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT gemaminana noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT ingridcardells noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT patriciapalau noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT paullacer noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT lorenzofacila noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT luisalmenar noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT mariaplopezlereu noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT josevmonmeneu noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT martinaamiguet noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT jessikagonzalez noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT aliciaserrano noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT vicentemontagud noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT raquellopezvilella noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT ernestovalero noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT sergiogarciablas noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT vicentbodi noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT rafaeldelaespriellajuan noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT joseplupon noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT jorgenavarro noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT joseluisgorriz noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT juansanchis noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT franciscojchorro noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT josepcomincolet noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial AT antonibayesgenis noninvasiveimagingestimationofmyocardialironrepletionfollowingadministrationofintravenousironthemyocardialirontrial |