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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps</title>
<author><name sortKey="Mentz, Robert J" sort="Mentz, Robert J" uniqKey="Mentz R" first="Robert J." last="Mentz">Robert J. Mentz</name>
<affiliation><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Roessig, Lothar" sort="Roessig, Lothar" uniqKey="Roessig L" first="Lothar" last="Roessig">Lothar Roessig</name>
<affiliation><nlm:aff id="A2">Bayer HealthCare, Wuppertal, Germany</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Greenberg, Barry H" sort="Greenberg, Barry H" uniqKey="Greenberg B" first="Barry H." last="Greenberg">Barry H. Greenberg</name>
<affiliation><nlm:aff id="A3">University of California at San Diego, San Diego, California, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sato, Naoki" sort="Sato, Naoki" uniqKey="Sato N" first="Naoki" last="Sato">Naoki Sato</name>
<affiliation><nlm:aff id="A4">Nippon Medical School Musashi-Kosugi Hospital, Kawasaki, Kanagawa, Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Shinagawa, Kaori" sort="Shinagawa, Kaori" uniqKey="Shinagawa K" first="Kaori" last="Shinagawa">Kaori Shinagawa</name>
<affiliation><nlm:aff id="A5">Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Yeo, Daniel" sort="Yeo, Daniel" uniqKey="Yeo D" first="Daniel" last="Yeo">Daniel Yeo</name>
<affiliation><nlm:aff id="A6">Gleneagles Hospital, Singapore</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kwok, Bernard W K" sort="Kwok, Bernard W K" uniqKey="Kwok B" first="Bernard W. K." last="Kwok">Bernard W. K. Kwok</name>
<affiliation><nlm:aff id="A7">Farrer Park Medical Centre, Singapore</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Reyes, Eugenio B" sort="Reyes, Eugenio B" uniqKey="Reyes E" first="Eugenio B." last="Reyes">Eugenio B. Reyes</name>
<affiliation><nlm:aff id="A8">Manila Doctors Hospital, Manila, Philippines</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name>
<affiliation><nlm:aff id="A9">Monash University, Melbourne, Australia</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pieske, Burkert" sort="Pieske, Burkert" uniqKey="Pieske B" first="Burkert" last="Pieske">Burkert Pieske</name>
<affiliation><nlm:aff id="A10">Charité University Medicine, Campus Virchow Klinikum, and German Heart Center Berlin, Berlin, Germany</nlm:aff>
</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><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</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><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kelly, Jacob P" sort="Kelly, Jacob P" uniqKey="Kelly J" first="Jacob P." last="Kelly">Jacob P. Kelly</name>
<affiliation><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name>
<affiliation><nlm:aff id="A11">Inserm Centre d’Investigation Clinique CIC 1433, UMR 1116, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name>
<affiliation><nlm:aff id="A12">University of Michigan School of Medicine, Ann Arbor, Michigan, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Lam, Carolyn S P" sort="Lam, Carolyn S P" uniqKey="Lam C" first="Carolyn S. P." last="Lam">Carolyn S. P. Lam</name>
<affiliation><nlm:aff id="A13">National Heart Centre Singapore and Duke-National University of Singapore, Singapore</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">27256745</idno>
<idno type="pmc">4893168</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4893168</idno>
<idno type="RBID">PMC:4893168</idno>
<idno type="doi">10.1016/j.jchf.2016.01.013</idno>
<date when="2016">2016</date>
<idno type="wicri:Area/Pmc/Corpus">001E85</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps</title>
<author><name sortKey="Mentz, Robert J" sort="Mentz, Robert J" uniqKey="Mentz R" first="Robert J." last="Mentz">Robert J. Mentz</name>
<affiliation><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Roessig, Lothar" sort="Roessig, Lothar" uniqKey="Roessig L" first="Lothar" last="Roessig">Lothar Roessig</name>
<affiliation><nlm:aff id="A2">Bayer HealthCare, Wuppertal, Germany</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Greenberg, Barry H" sort="Greenberg, Barry H" uniqKey="Greenberg B" first="Barry H." last="Greenberg">Barry H. Greenberg</name>
<affiliation><nlm:aff id="A3">University of California at San Diego, San Diego, California, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sato, Naoki" sort="Sato, Naoki" uniqKey="Sato N" first="Naoki" last="Sato">Naoki Sato</name>
<affiliation><nlm:aff id="A4">Nippon Medical School Musashi-Kosugi Hospital, Kawasaki, Kanagawa, Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Shinagawa, Kaori" sort="Shinagawa, Kaori" uniqKey="Shinagawa K" first="Kaori" last="Shinagawa">Kaori Shinagawa</name>
<affiliation><nlm:aff id="A5">Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Yeo, Daniel" sort="Yeo, Daniel" uniqKey="Yeo D" first="Daniel" last="Yeo">Daniel Yeo</name>
<affiliation><nlm:aff id="A6">Gleneagles Hospital, Singapore</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kwok, Bernard W K" sort="Kwok, Bernard W K" uniqKey="Kwok B" first="Bernard W. K." last="Kwok">Bernard W. K. Kwok</name>
<affiliation><nlm:aff id="A7">Farrer Park Medical Centre, Singapore</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Reyes, Eugenio B" sort="Reyes, Eugenio B" uniqKey="Reyes E" first="Eugenio B." last="Reyes">Eugenio B. Reyes</name>
<affiliation><nlm:aff id="A8">Manila Doctors Hospital, Manila, Philippines</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name>
<affiliation><nlm:aff id="A9">Monash University, Melbourne, Australia</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pieske, Burkert" sort="Pieske, Burkert" uniqKey="Pieske B" first="Burkert" last="Pieske">Burkert Pieske</name>
<affiliation><nlm:aff id="A10">Charité University Medicine, Campus Virchow Klinikum, and German Heart Center Berlin, Berlin, Germany</nlm:aff>
</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><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</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><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Kelly, Jacob P" sort="Kelly, Jacob P" uniqKey="Kelly J" first="Jacob P." last="Kelly">Jacob P. Kelly</name>
<affiliation><nlm:aff id="A1">Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name>
<affiliation><nlm:aff id="A11">Inserm Centre d’Investigation Clinique CIC 1433, UMR 1116, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name>
<affiliation><nlm:aff id="A12">University of Michigan School of Medicine, Ann Arbor, Michigan, USA</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Lam, Carolyn S P" sort="Lam, Carolyn S P" uniqKey="Lam C" first="Carolyn S. P." last="Lam">Carolyn S. P. Lam</name>
<affiliation><nlm:aff id="A13">National Heart Centre Singapore and Duke-National University of Singapore, Singapore</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">JACC. Heart failure</title>
<idno type="ISSN">2213-1779</idno>
<idno type="eISSN">2213-1787</idno>
<imprint><date when="2016">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p id="P1">Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF with similarly poor outcomes compared to the rest of the world. Representation of Asians in landmark HF trials has been variable. In addition, HF patients from Asia demonstrate clinical differences from other geographic regions. Thus, the generalizability of some clinical trials results to the Asian population remains uncertain. In this manuscript, we review differences in the HF phenotype, management and outcomes in patients from East and Southeast Asia. We describe lessons learned in Asia from recent HF registries and clinical trial databases and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, industry representatives and regulatory representatives at the CardioVascular Clinical Trialist Asia Forum on July 4, 2014.</p>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101598241</journal-id>
<journal-id journal-id-type="pubmed-jr-id">40896</journal-id>
<journal-id journal-id-type="nlm-ta">JACC Heart Fail</journal-id>
<journal-id journal-id-type="iso-abbrev">JACC Heart Fail</journal-id>
<journal-title-group><journal-title>JACC. Heart failure</journal-title>
</journal-title-group>
<issn pub-type="ppub">2213-1779</issn>
<issn pub-type="epub">2213-1787</issn>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">27256745</article-id>
<article-id pub-id-type="pmc">4893168</article-id>
<article-id pub-id-type="doi">10.1016/j.jchf.2016.01.013</article-id>
<article-id pub-id-type="manuscript">NIHMS768836</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Mentz</surname>
<given-names>Robert J.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Roessig</surname>
<given-names>Lothar</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Greenberg</surname>
<given-names>Barry H.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sato</surname>
<given-names>Naoki</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Shinagawa</surname>
<given-names>Kaori</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref ref-type="aff" rid="A5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Yeo</surname>
<given-names>Daniel</given-names>
</name>
<degrees>MBBS</degrees>
<xref ref-type="aff" rid="A6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kwok</surname>
<given-names>Bernard W.K.</given-names>
</name>
<degrees>MBBS</degrees>
<xref ref-type="aff" rid="A7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Reyes</surname>
<given-names>Eugenio B.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Krum</surname>
<given-names>Henry</given-names>
</name>
<degrees>MBBS, PhD</degrees>
<xref ref-type="aff" rid="A9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pieske</surname>
<given-names>Burkert</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Greene</surname>
<given-names>Stephen J.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Ambrosy</surname>
<given-names>Andrew P.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kelly</surname>
<given-names>Jacob P.</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Zannad</surname>
<given-names>Faiez</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pitt</surname>
<given-names>Bertram</given-names>
</name>
<degrees>MD</degrees>
<xref ref-type="aff" rid="A12">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lam</surname>
<given-names>Carolyn S.P.</given-names>
</name>
<degrees>MBBS</degrees>
<xref ref-type="aff" rid="A13">13</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>1</label>
Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA</aff>
<aff id="A2"><label>2</label>
Bayer HealthCare, Wuppertal, Germany</aff>
<aff id="A3"><label>3</label>
University of California at San Diego, San Diego, California, USA</aff>
<aff id="A4"><label>4</label>
Nippon Medical School Musashi-Kosugi Hospital, Kawasaki, Kanagawa, Japan</aff>
<aff id="A5"><label>5</label>
Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan</aff>
<aff id="A6"><label>6</label>
Gleneagles Hospital, Singapore</aff>
<aff id="A7"><label>7</label>
Farrer Park Medical Centre, Singapore</aff>
<aff id="A8"><label>8</label>
Manila Doctors Hospital, Manila, Philippines</aff>
<aff id="A9"><label>9</label>
Monash University, Melbourne, Australia</aff>
<aff id="A10"><label>10</label>
Charité University Medicine, Campus Virchow Klinikum, and German Heart Center Berlin, Berlin, Germany</aff>
<aff id="A11"><label>11</label>
Inserm Centre d’Investigation Clinique CIC 1433, UMR 1116, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France</aff>
<aff id="A12"><label>12</label>
University of Michigan School of Medicine, Ann Arbor, Michigan, USA</aff>
<aff id="A13"><label>13</label>
National Heart Centre Singapore and Duke-National University of Singapore, Singapore</aff>
<author-notes><corresp id="FN1"><bold>Address for correspondence:</bold>
Robert J. Mentz, MD, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715; telephone: 919-668-7121; fax: 919-668-7063; <email>robert.mentz@duke.edu</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>19</day>
<month>3</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="ppub"><month>6</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>01</day>
<month>6</month>
<year>2017</year>
</pub-date>
<volume>4</volume>
<issue>6</issue>
<fpage>419</fpage>
<lpage>427</lpage>
<pmc-comment>elocation-id from pubmed: 10.1016/j.jchf.2016.01.013</pmc-comment>
<abstract><p id="P1">Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF with similarly poor outcomes compared to the rest of the world. Representation of Asians in landmark HF trials has been variable. In addition, HF patients from Asia demonstrate clinical differences from other geographic regions. Thus, the generalizability of some clinical trials results to the Asian population remains uncertain. In this manuscript, we review differences in the HF phenotype, management and outcomes in patients from East and Southeast Asia. We describe lessons learned in Asia from recent HF registries and clinical trial databases and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, industry representatives and regulatory representatives at the CardioVascular Clinical Trialist Asia Forum on July 4, 2014.</p>
</abstract>
<kwd-group><kwd>Heart failure</kwd>
<kwd>Asia</kwd>
<kwd>Trials</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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