Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.
Identifieur interne : 000077 ( Main/Exploration ); précédent : 000076; suivant : 000078Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.
Auteurs : Douglas L. Mann [États-Unis] ; Stephen J. Greene [États-Unis] ; Michael M. Givertz [États-Unis] ; Justin M. Vader [États-Unis] ; Randall C. Starling [États-Unis] ; Andrew P. Ambrosy [États-Unis] ; Palak Shah [États-Unis] ; Steven E. Mcnulty [États-Unis] ; Claudius Mahr [États-Unis] ; Divya Gupta [Géorgie (pays)] ; Margaret M. Redfield [États-Unis] ; Anuradha Lala [États-Unis] ; Gregory D. Lewis [États-Unis] ; Selma F. Mohammed [États-Unis] ; Nisha A. Gilotra [États-Unis] ; Adam D. Devore [États-Unis] ; Eiran Z. Gorodeski [États-Unis] ; Patrice Desvigne-Nickens [États-Unis] ; Adrian F. Hernandez [États-Unis] ; Eugene Braunwald [États-Unis]Source :
- JACC. Heart failure [ 2213-1787 ] ; 2020.
Descripteurs français
- KwdFr :
- Amino-butyrates (usage thérapeutique), Antagonistes des récepteurs aux angiotensines (usage thérapeutique), Arrêt précoce d'essais cliniques (MeSH), Association médicamenteuse (MeSH), Betacoronavirus (MeSH), Cardiotoniques (usage thérapeutique), Dispositifs d'assistance circulatoire (MeSH), Débit de filtration glomérulaire (MeSH), Débit systolique (MeSH), Défaillance cardiaque (métabolisme), Défaillance cardiaque (physiopathologie), Défaillance cardiaque (traitement médicamenteux), Fragments peptidiques (métabolisme), Hospitalisation (statistiques et données numériques), Humains (MeSH), Hypotension artérielle (induit chimiquement), Infections à coronavirus (MeSH), Méthode en double aveugle (MeSH), Pandémies (MeSH), Peptide natriurétique cérébral (métabolisme), Pneumopathie virale (MeSH), Relation dose-effet des médicaments (MeSH), Transplantation cardiaque (MeSH), Tétrazoles (usage thérapeutique).
- MESH :
- induit chimiquement : Hypotension artérielle.
- métabolisme : Défaillance cardiaque, Fragments peptidiques, Peptide natriurétique cérébral.
- physiopathologie : Défaillance cardiaque.
- statistiques et données numériques : Hospitalisation.
- traitement médicamenteux : Défaillance cardiaque.
- usage thérapeutique : Amino-butyrates, Antagonistes des récepteurs aux angiotensines, Cardiotoniques, Tétrazoles.
- Arrêt précoce d'essais cliniques, Association médicamenteuse, Betacoronavirus, Dispositifs d'assistance circulatoire, Débit de filtration glomérulaire, Débit systolique, Humains, Infections à coronavirus, Méthode en double aveugle, Pandémies, Pneumopathie virale, Relation dose-effet des médicaments, Transplantation cardiaque.
English descriptors
- KwdEn :
- Aminobutyrates (therapeutic use), Angiotensin Receptor Antagonists (therapeutic use), Betacoronavirus (MeSH), COVID-19 (MeSH), Cardiotonic Agents (therapeutic use), Coronavirus Infections (MeSH), Dose-Response Relationship, Drug (MeSH), Double-Blind Method (MeSH), Drug Combinations (MeSH), Early Termination of Clinical Trials (MeSH), Glomerular Filtration Rate (MeSH), Heart Failure (drug therapy), Heart Failure (metabolism), Heart Failure (physiopathology), Heart Transplantation (MeSH), Heart-Assist Devices (MeSH), Hospitalization (statistics & numerical data), Humans (MeSH), Hypotension (chemically induced), Natriuretic Peptide, Brain (metabolism), Pandemics (MeSH), Peptide Fragments (metabolism), Pneumonia, Viral (MeSH), SARS-CoV-2 (MeSH), Stroke Volume (MeSH), Tetrazoles (therapeutic use).
- MESH :
- chemical , metabolism : Natriuretic Peptide, Brain, Peptide Fragments.
- chemical , therapeutic use : Aminobutyrates, Angiotensin Receptor Antagonists, Cardiotonic Agents, Tetrazoles.
- chemically induced : Hypotension.
- drug therapy : Heart Failure.
- metabolism : Heart Failure.
- physiopathology : Heart Failure.
- statistics & numerical data : Hospitalization.
- Betacoronavirus, COVID-19, Coronavirus Infections, Dose-Response Relationship, Drug, Double-Blind Method, Drug Combinations, Early Termination of Clinical Trials, Glomerular Filtration Rate, Heart Transplantation, Heart-Assist Devices, Humans, Pandemics, Pneumonia, Viral, SARS-CoV-2, Stroke Volume.
Abstract
The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).
DOI: 10.1016/j.jchf.2020.05.005
PubMed: 32641226
PubMed Central: PMC7286640
Affiliations:
- Géorgie (pays), États-Unis
- Californie, Caroline du Nord, District de Columbia, Maryland, Massachusetts, Minnesota, Missouri (État), Ohio, Virginie, Washington (État), État de New York
Links toward previous steps (curation, corpus...)
Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.</title>
<author><name sortKey="Mann, Douglas L" sort="Mann, Douglas L" uniqKey="Mann D" first="Douglas L" last="Mann">Douglas L. Mann</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Missouri (État)</region>
</placeName>
<wicri:cityArea>Department of Medicine, Washington University, St. Louis</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Greene, Stephen J" sort="Greene, Stephen J" uniqKey="Greene S" first="Stephen J" last="Greene">Stephen J. Greene</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Givertz, Michael M" sort="Givertz, Michael M" uniqKey="Givertz M" first="Michael M" last="Givertz">Michael M. Givertz</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Vader, Justin M" sort="Vader, Justin M" uniqKey="Vader J" first="Justin M" last="Vader">Justin M. Vader</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Washington University, St. Louis, Missouri.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Missouri (État)</region>
</placeName>
<wicri:cityArea>Department of Medicine, Washington University, St. Louis</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Starling, Randall C" sort="Starling, Randall C" uniqKey="Starling R" first="Randall C" last="Starling">Randall C. Starling</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Ohio</region>
</placeName>
<wicri:cityArea>Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Ambrosy, Andrew P" sort="Ambrosy, Andrew P" uniqKey="Ambrosy A" first="Andrew P" last="Ambrosy">Andrew P. Ambrosy</name>
<affiliation wicri:level="2"><nlm:affiliation>Division of Research, Kaiser Permanente Northern California, Oakland, California.</nlm:affiliation>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>Division of Research, Kaiser Permanente Northern California, Oakland</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Shah, Palak" sort="Shah, Palak" uniqKey="Shah P" first="Palak" last="Shah">Palak Shah</name>
<affiliation wicri:level="2"><nlm:affiliation>Inova Heart and Vascular Institute, Falls Church, Virginia.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Virginie</region>
</placeName>
<wicri:cityArea>Inova Heart and Vascular Institute, Falls Church</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Mcnulty, Steven E" sort="Mcnulty, Steven E" uniqKey="Mcnulty S" first="Steven E" last="Mcnulty">Steven E. Mcnulty</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Duke Clinical Research Institute, Duke University, Durham</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Mahr, Claudius" sort="Mahr, Claudius" uniqKey="Mahr C" first="Claudius" last="Mahr">Claudius Mahr</name>
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<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Washington (État)</region>
</placeName>
<wicri:cityArea>Department of Medicine, University of Washington, Seattle</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Gupta, Divya" sort="Gupta, Divya" uniqKey="Gupta D" first="Divya" last="Gupta">Divya Gupta</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, Emory University, Atlanta, Georgia.</nlm:affiliation>
<country xml:lang="fr">Géorgie (pays)</country>
<wicri:regionArea>Department of Medicine, Emory University, Atlanta</wicri:regionArea>
<wicri:noRegion>Atlanta</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Redfield, Margaret M" sort="Redfield, Margaret M" uniqKey="Redfield M" first="Margaret M" last="Redfield">Margaret M. Redfield</name>
<affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Division of Cardiovascular Diseases, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Lala, Anuradha" sort="Lala, Anuradha" uniqKey="Lala A" first="Anuradha" last="Lala">Anuradha Lala</name>
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<placeName><region type="state">État de New York</region>
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<author><name sortKey="Lewis, Gregory D" sort="Lewis, Gregory D" uniqKey="Lewis G" first="Gregory D" last="Lewis">Gregory D. Lewis</name>
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<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Department of Medicine, Massachusetts General Hospital, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Mohammed, Selma F" sort="Mohammed, Selma F" uniqKey="Mohammed S" first="Selma F" last="Mohammed">Selma F. Mohammed</name>
<affiliation wicri:level="2"><nlm:affiliation>MedStar Washington Hospital Center, Washington, DC.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">District de Columbia</region>
</placeName>
<wicri:cityArea>MedStar Washington Hospital Center, Washington</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Gilotra, Nisha A" sort="Gilotra, Nisha A" uniqKey="Gilotra N" first="Nisha A" last="Gilotra">Nisha A. Gilotra</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Department of Medicine, Johns Hopkins University School of Medicine, Baltimore</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Devore, Adam D" sort="Devore, Adam D" uniqKey="Devore A" first="Adam D" last="Devore">Adam D. Devore</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Gorodeski, Eiran Z" sort="Gorodeski, Eiran Z" uniqKey="Gorodeski E" first="Eiran Z" last="Gorodeski">Eiran Z. Gorodeski</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Ohio</region>
</placeName>
<wicri:cityArea>Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Desvigne Nickens, Patrice" sort="Desvigne Nickens, Patrice" uniqKey="Desvigne Nickens P" first="Patrice" last="Desvigne-Nickens">Patrice Desvigne-Nickens</name>
<affiliation wicri:level="2"><nlm:affiliation>Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
<wicri:cityArea>Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hernandez, Adrian F" sort="Hernandez, Adrian F" uniqKey="Hernandez A" first="Adrian F" last="Hernandez">Adrian F. Hernandez</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Caroline du Nord</region>
</placeName>
<wicri:cityArea>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Braunwald, Eugene" sort="Braunwald, Eugene" uniqKey="Braunwald E" first="Eugene" last="Braunwald">Eugene Braunwald</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston</wicri:cityArea>
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<series><title level="j">JACC. Heart failure</title>
<idno type="eISSN">2213-1787</idno>
<imprint><date when="2020" type="published">2020</date>
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<term>Angiotensin Receptor Antagonists (therapeutic use)</term>
<term>Betacoronavirus (MeSH)</term>
<term>COVID-19 (MeSH)</term>
<term>Cardiotonic Agents (therapeutic use)</term>
<term>Coronavirus Infections (MeSH)</term>
<term>Dose-Response Relationship, Drug (MeSH)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Drug Combinations (MeSH)</term>
<term>Early Termination of Clinical Trials (MeSH)</term>
<term>Glomerular Filtration Rate (MeSH)</term>
<term>Heart Failure (drug therapy)</term>
<term>Heart Failure (metabolism)</term>
<term>Heart Failure (physiopathology)</term>
<term>Heart Transplantation (MeSH)</term>
<term>Heart-Assist Devices (MeSH)</term>
<term>Hospitalization (statistics & numerical data)</term>
<term>Humans (MeSH)</term>
<term>Hypotension (chemically induced)</term>
<term>Natriuretic Peptide, Brain (metabolism)</term>
<term>Pandemics (MeSH)</term>
<term>Peptide Fragments (metabolism)</term>
<term>Pneumonia, Viral (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>Stroke Volume (MeSH)</term>
<term>Tetrazoles (therapeutic use)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Amino-butyrates (usage thérapeutique)</term>
<term>Antagonistes des récepteurs aux angiotensines (usage thérapeutique)</term>
<term>Arrêt précoce d'essais cliniques (MeSH)</term>
<term>Association médicamenteuse (MeSH)</term>
<term>Betacoronavirus (MeSH)</term>
<term>Cardiotoniques (usage thérapeutique)</term>
<term>Dispositifs d'assistance circulatoire (MeSH)</term>
<term>Débit de filtration glomérulaire (MeSH)</term>
<term>Débit systolique (MeSH)</term>
<term>Défaillance cardiaque (métabolisme)</term>
<term>Défaillance cardiaque (physiopathologie)</term>
<term>Défaillance cardiaque (traitement médicamenteux)</term>
<term>Fragments peptidiques (métabolisme)</term>
<term>Hospitalisation (statistiques et données numériques)</term>
<term>Humains (MeSH)</term>
<term>Hypotension artérielle (induit chimiquement)</term>
<term>Infections à coronavirus (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Peptide natriurétique cérébral (métabolisme)</term>
<term>Pneumopathie virale (MeSH)</term>
<term>Relation dose-effet des médicaments (MeSH)</term>
<term>Transplantation cardiaque (MeSH)</term>
<term>Tétrazoles (usage thérapeutique)</term>
</keywords>
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<term>Peptide Fragments</term>
</keywords>
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<term>Angiotensin Receptor Antagonists</term>
<term>Cardiotonic Agents</term>
<term>Tetrazoles</term>
</keywords>
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</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Hypotension artérielle</term>
</keywords>
<keywords scheme="MESH" qualifier="metabolism" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Défaillance cardiaque</term>
<term>Fragments peptidiques</term>
<term>Peptide natriurétique cérébral</term>
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<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Défaillance cardiaque</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Hospitalization</term>
</keywords>
<keywords scheme="MESH" qualifier="statistiques et données numériques" xml:lang="fr"><term>Hospitalisation</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Défaillance cardiaque</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Amino-butyrates</term>
<term>Antagonistes des récepteurs aux angiotensines</term>
<term>Cardiotoniques</term>
<term>Tétrazoles</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Betacoronavirus</term>
<term>COVID-19</term>
<term>Coronavirus Infections</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Combinations</term>
<term>Early Termination of Clinical Trials</term>
<term>Glomerular Filtration Rate</term>
<term>Heart Transplantation</term>
<term>Heart-Assist Devices</term>
<term>Humans</term>
<term>Pandemics</term>
<term>Pneumonia, Viral</term>
<term>SARS-CoV-2</term>
<term>Stroke Volume</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Arrêt précoce d'essais cliniques</term>
<term>Association médicamenteuse</term>
<term>Betacoronavirus</term>
<term>Dispositifs d'assistance circulatoire</term>
<term>Débit de filtration glomérulaire</term>
<term>Débit systolique</term>
<term>Humains</term>
<term>Infections à coronavirus</term>
<term>Méthode en double aveugle</term>
<term>Pandémies</term>
<term>Pneumopathie virale</term>
<term>Relation dose-effet des médicaments</term>
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<front><div type="abstract" xml:lang="en">The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32641226</PMID>
<DateCompleted><Year>2020</Year>
<Month>10</Month>
<Day>09</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>12</Month>
<Day>10</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2213-1787</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>8</Volume>
<Issue>10</Issue>
<PubDate><Year>2020</Year>
<Month>10</Month>
</PubDate>
</JournalIssue>
<Title>JACC. Heart failure</Title>
<ISOAbbreviation>JACC Heart Fail</ISOAbbreviation>
</Journal>
<ArticleTitle>Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.</ArticleTitle>
<Pagination><MedlinePgn>789-799</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S2213-1779(20)30272-9</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jchf.2020.05.005</ELocationID>
<Abstract><AbstractText>The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).</AbstractText>
<CopyrightInformation>Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mann</LastName>
<ForeName>Douglas L</ForeName>
<Initials>DL</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Greene</LastName>
<ForeName>Stephen J</ForeName>
<Initials>SJ</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Givertz</LastName>
<ForeName>Michael M</ForeName>
<Initials>MM</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Vader</LastName>
<ForeName>Justin M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Washington University, St. Louis, Missouri.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Starling</LastName>
<ForeName>Randall C</ForeName>
<Initials>RC</Initials>
<AffiliationInfo><Affiliation>Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ambrosy</LastName>
<ForeName>Andrew P</ForeName>
<Initials>AP</Initials>
<AffiliationInfo><Affiliation>Division of Research, Kaiser Permanente Northern California, Oakland, California.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shah</LastName>
<ForeName>Palak</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Inova Heart and Vascular Institute, Falls Church, Virginia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McNulty</LastName>
<ForeName>Steven E</ForeName>
<Initials>SE</Initials>
<AffiliationInfo><Affiliation>Duke Clinical Research Institute, Duke University, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mahr</LastName>
<ForeName>Claudius</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, University of Washington, Seattle, Washington.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gupta</LastName>
<ForeName>Divya</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Emory University, Atlanta, Georgia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Redfield</LastName>
<ForeName>Margaret M</ForeName>
<Initials>MM</Initials>
<AffiliationInfo><Affiliation>Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lala</LastName>
<ForeName>Anuradha</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Icahn School of Medicine at Mount Sinai, New York, New York.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lewis</LastName>
<ForeName>Gregory D</ForeName>
<Initials>GD</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mohammed</LastName>
<ForeName>Selma F</ForeName>
<Initials>SF</Initials>
<AffiliationInfo><Affiliation>MedStar Washington Hospital Center, Washington, DC.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gilotra</LastName>
<ForeName>Nisha A</ForeName>
<Initials>NA</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>DeVore</LastName>
<ForeName>Adam D</ForeName>
<Initials>AD</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gorodeski</LastName>
<ForeName>Eiran Z</ForeName>
<Initials>EZ</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Desvigne-Nickens</LastName>
<ForeName>Patrice</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hernandez</LastName>
<ForeName>Adrian F</ForeName>
<Initials>AF</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Braunwald</LastName>
<ForeName>Eugene</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>LIFE Investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT02816736</AccessionNumber>
</AccessionNumberList>
</DataBank>
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<GrantList CompleteYN="Y"><Grant><GrantID>U10 HL110309</GrantID>
<Acronym>HL</Acronym>
<Agency>NHLBI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>U10 HL110337</GrantID>
<Acronym>HL</Acronym>
<Agency>NHLBI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
<Grant><GrantID>U10 HL110342</GrantID>
<Acronym>HL</Acronym>
<Agency>NHLBI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
</GrantList>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>06</Month>
<Day>10</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>JACC Heart Fail</MedlineTA>
<NlmUniqueID>101598241</NlmUniqueID>
<ISSNLinking>2213-1779</ISSNLinking>
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<NameOfSubstance UI="D000613">Aminobutyrates</NameOfSubstance>
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<NameOfSubstance UI="D002316">Cardiotonic Agents</NameOfSubstance>
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<NameOfSubstance UI="D013777">Tetrazoles</NameOfSubstance>
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<NameOfSubstance UI="C109794">pro-brain natriuretic peptide (1-76)</NameOfSubstance>
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<NameOfSubstance UI="D020097">Natriuretic Peptide, Brain</NameOfSubstance>
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<Chemical><RegistryNumber>WB8FT61183</RegistryNumber>
<NameOfSubstance UI="C549068">sacubitril-valsartan</NameOfSubstance>
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<SupplMeshName Type="Organism" UI="C000656484">severe acute respiratory syndrome coronavirus 2</SupplMeshName>
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<CitationSubset>IM</CitationSubset>
<CommentsCorrectionsList><CommentsCorrections RefType="ErratumIn"><RefSource>JACC Heart Fail. 2020 Dec;8(12):1059</RefSource>
<PMID Version="1">33272389</PMID>
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<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
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</MeshHeading>
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<MeshHeading><DescriptorName UI="D057239" MajorTopicYN="N">Early Termination of Clinical Trials</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005919" MajorTopicYN="N">Glomerular Filtration Rate</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006333" MajorTopicYN="N">Heart Failure</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
<QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016027" MajorTopicYN="N">Heart Transplantation</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006353" MajorTopicYN="N">Heart-Assist Devices</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006760" MajorTopicYN="N">Hospitalization</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007022" MajorTopicYN="N">Hypotension</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D020097" MajorTopicYN="N">Natriuretic Peptide, Brain</DescriptorName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
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<MeshHeading><DescriptorName UI="D010446" MajorTopicYN="N">Peptide Fragments</DescriptorName>
<QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013318" MajorTopicYN="N">Stroke Volume</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013777" MajorTopicYN="N">Tetrazoles</DescriptorName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">NYHA functional class IV</Keyword>
<Keyword MajorTopicYN="Y">heart failure</Keyword>
<Keyword MajorTopicYN="Y">sacubitril/valsartan</Keyword>
<Keyword MajorTopicYN="Y">valsartan</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>04</Month>
<Day>21</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2020</Year>
<Month>05</Month>
<Day>18</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>05</Month>
<Day>19</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>7</Month>
<Day>10</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>10</Month>
<Day>10</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>7</Month>
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<Hour>6</Hour>
<Minute>0</Minute>
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</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">32641226</ArticleId>
<ArticleId IdType="pii">S2213-1779(20)30272-9</ArticleId>
<ArticleId IdType="doi">10.1016/j.jchf.2020.05.005</ArticleId>
<ArticleId IdType="pmc">PMC7286640</ArticleId>
</ArticleIdList>
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</pubmed>
<affiliations><list><country><li>Géorgie (pays)</li>
<li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Caroline du Nord</li>
<li>District de Columbia</li>
<li>Maryland</li>
<li>Massachusetts</li>
<li>Minnesota</li>
<li>Missouri (État)</li>
<li>Ohio</li>
<li>Virginie</li>
<li>Washington (État)</li>
<li>État de New York</li>
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</list>
<tree><country name="États-Unis"><region name="Missouri (État)"><name sortKey="Mann, Douglas L" sort="Mann, Douglas L" uniqKey="Mann D" first="Douglas L" last="Mann">Douglas L. Mann</name>
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<name sortKey="Ambrosy, Andrew P" sort="Ambrosy, Andrew P" uniqKey="Ambrosy A" first="Andrew P" last="Ambrosy">Andrew P. Ambrosy</name>
<name sortKey="Braunwald, Eugene" sort="Braunwald, Eugene" uniqKey="Braunwald E" first="Eugene" last="Braunwald">Eugene Braunwald</name>
<name sortKey="Desvigne Nickens, Patrice" sort="Desvigne Nickens, Patrice" uniqKey="Desvigne Nickens P" first="Patrice" last="Desvigne-Nickens">Patrice Desvigne-Nickens</name>
<name sortKey="Devore, Adam D" sort="Devore, Adam D" uniqKey="Devore A" first="Adam D" last="Devore">Adam D. Devore</name>
<name sortKey="Gilotra, Nisha A" sort="Gilotra, Nisha A" uniqKey="Gilotra N" first="Nisha A" last="Gilotra">Nisha A. Gilotra</name>
<name sortKey="Givertz, Michael M" sort="Givertz, Michael M" uniqKey="Givertz M" first="Michael M" last="Givertz">Michael M. Givertz</name>
<name sortKey="Gorodeski, Eiran Z" sort="Gorodeski, Eiran Z" uniqKey="Gorodeski E" first="Eiran Z" last="Gorodeski">Eiran Z. Gorodeski</name>
<name sortKey="Greene, Stephen J" sort="Greene, Stephen J" uniqKey="Greene S" first="Stephen J" last="Greene">Stephen J. Greene</name>
<name sortKey="Hernandez, Adrian F" sort="Hernandez, Adrian F" uniqKey="Hernandez A" first="Adrian F" last="Hernandez">Adrian F. Hernandez</name>
<name sortKey="Lala, Anuradha" sort="Lala, Anuradha" uniqKey="Lala A" first="Anuradha" last="Lala">Anuradha Lala</name>
<name sortKey="Lewis, Gregory D" sort="Lewis, Gregory D" uniqKey="Lewis G" first="Gregory D" last="Lewis">Gregory D. Lewis</name>
<name sortKey="Mahr, Claudius" sort="Mahr, Claudius" uniqKey="Mahr C" first="Claudius" last="Mahr">Claudius Mahr</name>
<name sortKey="Mcnulty, Steven E" sort="Mcnulty, Steven E" uniqKey="Mcnulty S" first="Steven E" last="Mcnulty">Steven E. Mcnulty</name>
<name sortKey="Mohammed, Selma F" sort="Mohammed, Selma F" uniqKey="Mohammed S" first="Selma F" last="Mohammed">Selma F. Mohammed</name>
<name sortKey="Redfield, Margaret M" sort="Redfield, Margaret M" uniqKey="Redfield M" first="Margaret M" last="Redfield">Margaret M. Redfield</name>
<name sortKey="Shah, Palak" sort="Shah, Palak" uniqKey="Shah P" first="Palak" last="Shah">Palak Shah</name>
<name sortKey="Starling, Randall C" sort="Starling, Randall C" uniqKey="Starling R" first="Randall C" last="Starling">Randall C. Starling</name>
<name sortKey="Vader, Justin M" sort="Vader, Justin M" uniqKey="Vader J" first="Justin M" last="Vader">Justin M. Vader</name>
</country>
<country name="Géorgie (pays)"><noRegion><name sortKey="Gupta, Divya" sort="Gupta, Divya" uniqKey="Gupta D" first="Divya" last="Gupta">Divya Gupta</name>
</noRegion>
</country>
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</record>
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