Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure.
Identifieur interne : 000489 ( Main/Exploration ); précédent : 000488; suivant : 000490Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure.
Auteurs : Milton Packer [États-Unis] ; Richard Holcomb [États-Unis] ; William T. Abraham [États-Unis] ; Stefan Anker [Allemagne] ; Kenneth Dickstein [Norvège] ; Gerasimos Filippatos [Grèce] ; Henry Krum [Australie] ; Aldo P. Maggioni [Italie] ; John J V. Mcmurray [Royaume-Uni] ; Alexandre Mebazaa [France] ; Christopher O'Connor [États-Unis] ; Frank Peacock [États-Unis] ; Piotr Ponikowski [Pologne] ; Frank Ruschitzka [Suisse] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Johannes Holzmeister [Suisse]Source :
- European journal of heart failure [ 1879-0844 ] ; 2017.
Abstract
The TRUE-AHF is a randomized, double-blind, parallel-group, placebo-controlled trial which is evaluating the effects of a 48-h infusion of ularitide (15 ng/kg/min) on the short- and long-term clinical course of patients with acute heart failure. Noteworthy features of the study include the early enrolment of patients following their initial clinical presentation (within 12 h), and entry blood pressure criteria and thresholds for the adjustment of drug infusion rates, which aim to minimize the risk of hypotension. The trial has two primary endpoints: (i) cardiovascular mortality during long-term follow-up; and (ii) the clinical course of patients during their index hospitalization. Cardiovascular mortality is evaluated in this event-driven trial by following all randomized patients for the occurrence of death until the end of the entire study without truncation at an arbitrarily determined early time point. The clinical course during the index hospitalization is evaluated using the hierarchical clinical composite endpoint, which combines information regarding changes in symptoms and the occurrence of in-hospital worsening heart failure events and death into a single ranked metric that captures interval clinical events and minimizes the likelihood of missing data and confounding due to intensification of background therapy. The design of the TRUE-AHF trial capitalizes on lessons learned from earlier trials and aims to evaluate definitively the potential benefit of ularitide in patients with acute heart failure.
DOI: 10.1002/ejhf.698
PubMed: 27862700
Affiliations:
- Allemagne, Australie, France, Grèce, Italie, Norvège, Pays-Bas, Pologne, Royaume-Uni, Suisse, États-Unis
- Attique (région), Basse-Saxe, Groningue (province), Minnesota, Ohio, Texas, Victoria (État), Virginie, Écosse, Île-de-France
- Athènes, Glasgow, Groningue, Göttingen, Melbourne, Paris
- Université de Glasgow
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Van Veldhuisen</name><affiliation wicri:level="3"><nlm:affiliation>University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>University Medical Center Groningen, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Holzmeister, Johannes" sort="Holzmeister, Johannes" uniqKey="Holzmeister J" first="Johannes" last="Holzmeister">Johannes Holzmeister</name><affiliation wicri:level="1"><nlm:affiliation>Cardiology, University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Cardiology, University Hospital Zurich, Zurich</wicri:regionArea><wicri:noRegion>Zurich</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:27862700</idno><idno type="pmid">27862700</idno><idno type="doi">10.1002/ejhf.698</idno><idno type="wicri:Area/PubMed/Corpus">000C59</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000C59</idno><idno type="wicri:Area/PubMed/Curation">000C56</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000C56</idno><idno type="wicri:Area/PubMed/Checkpoint">000C56</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000C56</idno><idno type="wicri:Area/Ncbi/Merge">003E97</idno><idno type="wicri:Area/Ncbi/Curation">003E97</idno><idno type="wicri:Area/Ncbi/Checkpoint">003E97</idno><idno type="wicri:Area/Main/Merge">000484</idno><idno type="wicri:Area/Main/Curation">000489</idno><idno type="wicri:Area/Main/Exploration">000489</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure.</title><author><name sortKey="Packer, Milton" sort="Packer, Milton" uniqKey="Packer M" first="Milton" last="Packer">Milton Packer</name><affiliation wicri:level="2"><nlm:affiliation>Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Holcomb, Richard" sort="Holcomb, Richard" uniqKey="Holcomb R" first="Richard" last="Holcomb">Richard Holcomb</name><affiliation wicri:level="2"><nlm:affiliation>Study Biostatistician Wayzata, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Study Biostatistician Wayzata, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Abraham, William T" sort="Abraham, William T" uniqKey="Abraham W" first="William T" last="Abraham">William T. Abraham</name><affiliation wicri:level="2"><nlm:affiliation>Ohio State University Heart and Vascular Center, Columbus, OH, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Ohio State University Heart and Vascular Center, Columbus, OH</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Anker, Stefan" sort="Anker, Stefan" uniqKey="Anker S" first="Stefan" last="Anker">Stefan Anker</name><affiliation wicri:level="3"><nlm:affiliation>Innovative Clinical Trials, Department of Cardiology & Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Innovative Clinical Trials, Department of Cardiology & Pneumology, University Medical Center Göttingen (UMG), Göttingen</wicri:regionArea><placeName><region type="land" nuts="2">Basse-Saxe</region><settlement type="city">Göttingen</settlement></placeName></affiliation></author><author><name sortKey="Dickstein, Kenneth" sort="Dickstein, Kenneth" uniqKey="Dickstein K" first="Kenneth" last="Dickstein">Kenneth Dickstein</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiology, University of Bergen, Stavanger, Norway.</nlm:affiliation><country xml:lang="fr">Norvège</country><wicri:regionArea>Division of Cardiology, University of Bergen, Stavanger</wicri:regionArea><wicri:noRegion>Stavanger</wicri:noRegion></affiliation></author><author><name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name><affiliation wicri:level="3"><nlm:affiliation>National and Kapodistrian University of Athens, School of Medicine, Attikon Athens University Hospital, Department of Cardiology, Athens, Greece.</nlm:affiliation><country xml:lang="fr">Grèce</country><wicri:regionArea>National and Kapodistrian University of Athens, School of Medicine, Attikon Athens University Hospital, Department of Cardiology, Athens</wicri:regionArea><placeName><settlement type="city">Athènes</settlement><region nuts="2" type="region">Attique (région)</region></placeName></affiliation></author><author><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name><affiliation wicri:level="3"><nlm:affiliation>Monash University, Centre of Cardiovascular Research & Education in Therapeutics, Melbourne, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Monash University, Centre of Cardiovascular Research & Education in Therapeutics, Melbourne</wicri:regionArea><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName></affiliation></author><author><name sortKey="Maggioni, Aldo P" sort="Maggioni, Aldo P" uniqKey="Maggioni A" first="Aldo P" last="Maggioni">Aldo P. Maggioni</name><affiliation wicri:level="1"><nlm:affiliation>Centro Studi ANMCO, Fondazione 'per il Tuo cuore' HCF ONLUS, Firenze, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Centro Studi ANMCO, Fondazione 'per il Tuo cuore' HCF ONLUS, Firenze</wicri:regionArea><wicri:noRegion>Firenze</wicri:noRegion></affiliation></author><author><name sortKey="Mcmurray, John J V" sort="Mcmurray, John J V" uniqKey="Mcmurray J" first="John J V" last="Mcmurray">John J V. Mcmurray</name><affiliation wicri:level="4"><nlm:affiliation>Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><affiliation wicri:level="3"><nlm:affiliation>University of Paris, Department of Anesthesia and Critical Care, Hôpitaux Universitaire Saint Louis Lariboisière, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>University of Paris, Department of Anesthesia and Critical Care, Hôpitaux Universitaire Saint Louis Lariboisière, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="O Connor, Christopher" sort="O Connor, Christopher" uniqKey="O Connor C" first="Christopher" last="O'Connor">Christopher O'Connor</name><affiliation wicri:level="2"><nlm:affiliation>Inova Heart and Vascular Institute, Falls Church, VA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Inova Heart and Vascular Institute, Falls Church, VA</wicri:regionArea><placeName><region type="state">Virginie</region></placeName></affiliation></author><author><name sortKey="Peacock, Frank" sort="Peacock, Frank" uniqKey="Peacock F" first="Frank" last="Peacock">Frank Peacock</name><affiliation wicri:level="2"><nlm:affiliation>Baylor College of Medicine, Houston, TX, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Baylor College of Medicine, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name><affiliation wicri:level="1"><nlm:affiliation>Poland Wroclaw Medical University, Wroclaw, Poland.</nlm:affiliation><country xml:lang="fr">Pologne</country><wicri:regionArea>Poland Wroclaw Medical University, Wroclaw</wicri:regionArea><wicri:noRegion>Wroclaw</wicri:noRegion></affiliation></author><author><name sortKey="Ruschitzka, Frank" sort="Ruschitzka, Frank" uniqKey="Ruschitzka F" first="Frank" last="Ruschitzka">Frank Ruschitzka</name><affiliation wicri:level="1"><nlm:affiliation>Cardiology, University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Cardiology, University Hospital Zurich, Zurich</wicri:regionArea><wicri:noRegion>Zurich</wicri:noRegion></affiliation></author><author><name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J" last="Van Veldhuisen">Dirk J. Van Veldhuisen</name><affiliation wicri:level="3"><nlm:affiliation>University Medical Center Groningen, Groningen, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>University Medical Center Groningen, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Holzmeister, Johannes" sort="Holzmeister, Johannes" uniqKey="Holzmeister J" first="Johannes" last="Holzmeister">Johannes Holzmeister</name><affiliation wicri:level="1"><nlm:affiliation>Cardiology, University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Cardiology, University Hospital Zurich, Zurich</wicri:regionArea><wicri:noRegion>Zurich</wicri:noRegion></affiliation></author></analytic><series><title level="j">European journal of heart failure</title><idno type="eISSN">1879-0844</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The TRUE-AHF is a randomized, double-blind, parallel-group, placebo-controlled trial which is evaluating the effects of a 48-h infusion of ularitide (15 ng/kg/min) on the short- and long-term clinical course of patients with acute heart failure. Noteworthy features of the study include the early enrolment of patients following their initial clinical presentation (within 12 h), and entry blood pressure criteria and thresholds for the adjustment of drug infusion rates, which aim to minimize the risk of hypotension. The trial has two primary endpoints: (i) cardiovascular mortality during long-term follow-up; and (ii) the clinical course of patients during their index hospitalization. Cardiovascular mortality is evaluated in this event-driven trial by following all randomized patients for the occurrence of death until the end of the entire study without truncation at an arbitrarily determined early time point. The clinical course during the index hospitalization is evaluated using the hierarchical clinical composite endpoint, which combines information regarding changes in symptoms and the occurrence of in-hospital worsening heart failure events and death into a single ranked metric that captures interval clinical events and minimizes the likelihood of missing data and confounding due to intensification of background therapy. The design of the TRUE-AHF trial capitalizes on lessons learned from earlier trials and aims to evaluate definitively the potential benefit of ularitide in patients with acute heart failure.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>Grèce</li><li>Italie</li><li>Norvège</li><li>Pays-Bas</li><li>Pologne</li><li>Royaume-Uni</li><li>Suisse</li><li>États-Unis</li></country><region><li>Attique (région)</li><li>Basse-Saxe</li><li>Groningue (province)</li><li>Minnesota</li><li>Ohio</li><li>Texas</li><li>Victoria (État)</li><li>Virginie</li><li>Écosse</li><li>Île-de-France</li></region><settlement><li>Athènes</li><li>Glasgow</li><li>Groningue</li><li>Göttingen</li><li>Melbourne</li><li>Paris</li></settlement><orgName><li>Université de Glasgow</li></orgName></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Packer, Milton" sort="Packer, Milton" uniqKey="Packer M" first="Milton" last="Packer">Milton Packer</name></region><name sortKey="Abraham, William T" sort="Abraham, William T" uniqKey="Abraham W" first="William T" last="Abraham">William T. Abraham</name><name sortKey="Holcomb, Richard" sort="Holcomb, Richard" uniqKey="Holcomb R" first="Richard" last="Holcomb">Richard Holcomb</name><name sortKey="O Connor, Christopher" sort="O Connor, Christopher" uniqKey="O Connor C" first="Christopher" last="O'Connor">Christopher O'Connor</name><name sortKey="Peacock, Frank" sort="Peacock, Frank" uniqKey="Peacock F" first="Frank" last="Peacock">Frank Peacock</name></country><country name="Allemagne"><region name="Basse-Saxe"><name sortKey="Anker, Stefan" sort="Anker, Stefan" uniqKey="Anker S" first="Stefan" last="Anker">Stefan Anker</name></region></country><country name="Norvège"><noRegion><name sortKey="Dickstein, Kenneth" sort="Dickstein, Kenneth" uniqKey="Dickstein K" first="Kenneth" last="Dickstein">Kenneth Dickstein</name></noRegion></country><country name="Grèce"><region name="Attique (région)"><name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name></region></country><country name="Australie"><region name="Victoria (État)"><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name></region></country><country name="Italie"><noRegion><name sortKey="Maggioni, Aldo P" sort="Maggioni, Aldo P" uniqKey="Maggioni A" first="Aldo P" last="Maggioni">Aldo P. Maggioni</name></noRegion></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Mcmurray, John J V" sort="Mcmurray, John J V" uniqKey="Mcmurray J" first="John J V" last="Mcmurray">John J V. Mcmurray</name></region></country><country name="France"><region name="Île-de-France"><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name></region></country><country name="Pologne"><noRegion><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Ruschitzka, Frank" sort="Ruschitzka, Frank" uniqKey="Ruschitzka F" first="Frank" last="Ruschitzka">Frank Ruschitzka</name></noRegion><name sortKey="Holzmeister, Johannes" sort="Holzmeister, Johannes" uniqKey="Holzmeister J" first="Johannes" last="Holzmeister">Johannes Holzmeister</name></country><country name="Pays-Bas"><region name="Groningue (province)"><name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J" last="Van Veldhuisen">Dirk J. Van Veldhuisen</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure.
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