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  <front>
    <journal-meta>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
        <publisher-loc>S&#227;o Paulo, SP, Brazil</publisher-loc>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v3">CPmWrLKZ67tPQYkLnD7qXcw</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v2">S0066-782X2013000500001</article-id>
      <article-id pub-id-type="publisher-id" specific-use="scielo-v1">S0066-782X(13)10000500001</article-id>
      <article-id pub-id-type="doi">10.5935/abc.20130093</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Artigo Especial</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Racionalidade e m&#233;todos: estudo BREATHE - I registro brasileiro de insufici&#234;ncia card&#237;aca</article-title>
      </title-group>
      <pub-date date-type="collection" publication-format="electronic">
        <month>05</month>
        <year>2013</year>
      </pub-date>
      <volume>100</volume>
      <issue>5</issue>
      <fpage>390</fpage>
      <lpage>394</lpage>
      <history>
        <date date-type="received">
          <day>01</day>
          <month>03</month>
          <year>2013</year>
        </date>
        <date date-type="accepted">
          <day>28</day>
          <month>03</month>
          <year>2013</year>
        </date>
        <date date-type="rev-recd">
          <day>06</day>
          <month>03</month>
          <year>2013</year>
        </date>
      </history>
      <permissions>
        <license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/" xml:lang="en">
          <license-p>This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.</license-p>
        </license>
      </permissions>
      <abstract>
        <p>FUNDAMENTO: Diversos registros locais buscam de forma isolada retratar caracter&#237;sticas cl&#237;nicas de pacientes internados com Insufici&#234;ncia Card&#237;aca (IC) em hospitais e comunidades brasileiras. De forma geral, a an&#225;lise desses dados sugere que existam diferen&#231;as importantes na etiologia, nos fatores de descompensa&#231;&#227;o, no tratamento e no progn&#243;stico de pacientes com IC nas diferentes regi&#245;es brasileiras. OBJETIVOS: Avaliar as caracter&#237;sticas demogr&#225;ficas, cl&#237;nicas, progn&#243;sticas de 1.200 pacientes admitidos com diagn&#243;stico cl&#237;nico de insufici&#234;ncia card&#237;aca descompensada em um grupo de 60 hospitais representativos das diferentes regi&#245;es brasileiras. M&#201;TODOS: Estudo observacional transversal (registro) com seguimento longitudinal de doze meses (visitas de admiss&#227;o, alta hospitalar, tr&#234;s meses, seis meses e doze meses ap&#243;s inclus&#227;o), em que pacientes admitidos em hospitais da rede p&#250;blica e privada com quadro cl&#237;nico primariamente de IC definida ser&#227;o estudados. RESULTADOS: Os resultados ser&#227;o apresentados logo ap&#243;s o t&#233;rmino da coleta, avalia&#231;&#227;o da qualidade e an&#225;lise estat&#237;stica dos dados. CONCLUS&#213;ES: A an&#225;lise dos resultados deste registro multic&#234;ntrico permitir&#225; um planejamento mais adequado do aporte de recursos financeiros, pessoais e tecnol&#243;gicos para a &#225;rea da sa&#250;de, bem como o planejamento de medidas preventivas mais eficazes na IC descompensada.</p>
      </abstract>
      <kwd-group xml:lang="pt" kwd-group-type="author-generated">
        <kwd>Insufici&#234;ncia Card&#237;aca</kwd>
        <kwd>Registros M&#233;dicos</kwd>
        <kwd>Pacientes Internados</kwd>
        <kwd>Brasil</kwd>
      </kwd-group>
      <pub-date publication-format="electronic" date-type="pub">
        <day>28</day>
        <month>05</month>
        <year>2013</year>
      </pub-date>
    </article-meta>
  </front>
  <body>
    <p>
      <bold>ARTIGO ESPECIAL</bold>
    </p>
    <p>
      <bold>Racionalidade e m&#233;todos - estudo BREATHE - I registro brasileiro de insufici&#234;ncia card&#237;aca</bold>
    </p>
    <p>
      <bold>Em nome dos Investigadores do BREATHE</bold>
    </p>
    <p>Sociedade Brasileira de Cardiologia - Departamento de Insufici&#234;ncia Card&#237;aca (DEIC)</p>
    <p>
      <xref ref-type="corresp" rid="end">Correspond&#234;ncia</xref>
    </p>
    <p>
      <bold>RESUMO</bold>
    </p>
    <p><bold>FUNDAMENTO:</bold> Diversos registros locais buscam de forma isolada retratar caracter&#237;sticas cl&#237;nicas de pacientes internados com Insufici&#234;ncia Card&#237;aca (IC) em hospitais e comunidades brasileiras. De forma geral, a an&#225;lise desses dados sugere que existam diferen&#231;as importantes na etiologia, nos fatores de descompensa&#231;&#227;o, no tratamento e no progn&#243;stico de pacientes com IC nas diferentes regi&#245;es brasileiras. </p>
    <p><bold>OBJETIVOS:</bold> Avaliar as caracter&#237;sticas demogr&#225;ficas, cl&#237;nicas, progn&#243;sticas de 1.200 pacientes admitidos com diagn&#243;stico cl&#237;nico de insufici&#234;ncia card&#237;aca descompensada em um grupo de 60 hospitais representativos das diferentes regi&#245;es brasileiras. </p>
    <p><bold>M&#201;TODOS:</bold> Estudo observacional transversal (registro) com seguimento longitudinal de doze meses (visitas de admiss&#227;o, alta hospitalar, tr&#234;s meses, seis meses e doze meses ap&#243;s inclus&#227;o), em que pacientes admitidos em hospitais da rede p&#250;blica e privada com quadro cl&#237;nico primariamente de IC definida ser&#227;o estudados. </p>
    <p><bold>RESULTADOS:</bold> Os resultados ser&#227;o apresentados logo ap&#243;s o t&#233;rmino da coleta, avalia&#231;&#227;o da qualidade e an&#225;lise estat&#237;stica dos dados. </p>
    <p><bold>CONCLUS&#213;ES:</bold> A an&#225;lise dos resultados deste registro multic&#234;ntrico permitir&#225; um planejamento mais adequado do aporte de recursos financeiros, pessoais e tecnol&#243;gicos para a &#225;rea da sa&#250;de, bem como o planejamento de medidas preventivas mais eficazes na IC descompensada.</p>
    <p><bold>Palavras-chave:</bold> Insufici&#234;ncia Card&#237;aca, Registros M&#233;dicos, Pacientes Internados, Brasil.</p>
    <p>
      <bold>Introdu&#231;&#227;o</bold>
    </p>
    <p>A Insufici&#234;ncia Card&#237;aca (IC) &#233; uma s&#237;ndrome cl&#237;nica complexa de car&#225;ter sist&#234;mico, definida como disfun&#231;&#227;o card&#237;aca que ocasiona inadequado suprimento sangu&#237;neo para atender necessidades metab&#243;licas tissulares, na presen&#231;a de retorno venoso normal, ou faz&#234;-lo somente com elevadas press&#245;es de enchimento. As altera&#231;&#245;es hemodin&#226;micas comumente encontradas na IC envolvem resposta inadequada do d&#233;bito card&#237;aco e eleva&#231;&#227;o das press&#245;es pulmonar e venosa sist&#234;mica<sup>1,2</sup>. A IC &#233; uma das principais causas de mortalidade no Brasil e &#233; respons&#225;vel por um elevado n&#250;mero de admiss&#245;es hospitalares anuais (Dados do SUS, 2003). Nos Estados Unidos, IC afeta mais de cinco milh&#245;es de pessoas e surgem cerca de 550 mil novos casos anualmente<sup>3</sup>, sendo estimado que sua incid&#234;ncia atinja 10/1.000 pessoas ap&#243;s os 65 anos de idade.</p>
    <p>No Brasil e no resto do mundo, s&#227;o consistentes as evid&#234;ncias sobre a elevada taxa de admiss&#245;es hospitalares e visitas &#224; emerg&#234;ncia por intercorr&#234;ncias cl&#237;nicas associadas &#224; doen&#231;a. Entre os pacientes com mais de 70 anos admitidos por IC, 60% s&#227;o readmitidos em 90 dias<sup>4-6</sup>.</p>
    <p>O retrato mais abrangente da situa&#231;&#227;o das interna&#231;&#245;es por IC no Brasil pode ser obtido atrav&#233;s das an&#225;lises dos registros do DataSus, com as limita&#231;&#245;es inerentes de um banco de dados de car&#225;ter administrativo<sup>6</sup>. Dados referentes ao ano de 1997 demonstram que IC era uma causa muito frequente de interna&#231;&#227;o hospitalar (3,6% de todas as admiss&#245;es e 37% das interna&#231;&#245;es do aparelho circulat&#243;rio); al&#233;m de acarretar altas taxas de mortalidade intra-hospitalar (6,4% em 1997). Naquele ano, os gastos despendidos exclusivamente com as interna&#231;&#245;es por IC representavam 4,7% (ou aproximadamente 150 milh&#245;es de reais) do dinheiro gasto com admiss&#245;es hospitalares no SUS. Dados do DataSus referentes ao ano de 2007 apresentam redu&#231;&#227;o do n&#250;mero de interna&#231;&#245;es hospitalares nos &#250;ltimos dez anos, independentemente da faixa et&#225;ria com eleva&#231;&#227;o da taxa de mortalidade<sup>5,6</sup>.</p>
    <p>Diversos registros locais buscam de forma isolada retratar caracter&#237;sticas cl&#237;nicas de pacientes internados com IC em hospitais e comunidades brasileiras. De forma geral, a an&#225;lise desses dados sugere que existam diferen&#231;as importantes na etiologia, nos fatores de descompensa&#231;&#227;o, no tratamento e no progn&#243;stico de pacientes com IC nas diferentes regi&#245;es brasileiras<sup>7-9</sup>.</p>
    <p>
      <bold>M&#233;todos</bold>
    </p>
    <p>O Registro representa um projeto de documenta&#231;&#227;o da pr&#225;tica cl&#237;nica atual do atendimento a insufici&#234;ncia card&#237;aca descompensada no Brasil, para identificar a incorpora&#231;&#227;o de evid&#234;ncias na pr&#225;tica cl&#237;nica do tratamento dessa afec&#231;&#227;o, envolvendo hospitais p&#250;blicos e privados. Adicionalmente, ser&#225; realizado seguimento longitudinal desses pacientes at&#233; sua alta hospitalar e mortalidade em at&#233; 90, 180 e 365 dias.</p>
    <p>
      <bold>Delineamento</bold>
    </p>
    <p>Estudo observacional transversal (registro) com seguimento longitudinal.</p>
    <p>
      <bold>Sele&#231;&#227;o dos hospitais</bold>
    </p>
    <p>Os hospitais da rede p&#250;blica e privada que participar&#227;o do Registro de Insufici&#234;ncia Card&#237;aca Descompensada do DEIC ser&#227;o escolhidos pela comiss&#227;o de investigadores respeitando regras definidas <italic>a priori</italic>. Para cada uma das cinco regi&#245;es do pa&#237;s ser&#225; alocado um n&#250;mero fixo de pacientes que participar&#227;o do Registro. Cada hospital selecionado ter&#225; um coordenador institucional que se comprometer&#225; a registrar em at&#233; 12 meses pacientes consecutivamente com diagn&#243;stico cl&#237;nico de IC.</p>
    <p>
      <bold>Crit&#233;rios de inclus&#227;o e exclus&#227;o</bold>
    </p>
    <p>Pacientes admitidos em hospitais da rede p&#250;blica e privada com quadro cl&#237;nico primariamente de IC definida ser&#227;o estudados. Os crit&#233;rios utilizados para diagnosticar IC foram descritos previamente, validados e aplicados no nosso meio em estudos semelhantes no passado (<xref ref-type="table" rid="tab01">Tabela 1</xref>)<sup>10</sup>. Para inclus&#227;o no estudo os pacientes dever&#227;o ter um escore &gt; 7, fechando o diagn&#243;stico de IC definitiva.</p>
    <table-wrap id="tab01">
      <graphic xlink:href="1678-4170-abc-100-05-0390-30093-gt01.jpg"/></table-wrap>
    <p>Ser&#227;o exclu&#237;dos aqueles pacientes que foram submetidos a procedimentos de revasculariza&#231;&#227;o do mioc&#225;rdio (angioplastia ou cirurgia) no &#250;ltimo m&#234;s e pacientes que apresentam sinais de IC secund&#225;ria a um quadro de sepse.</p>
    <p>
      <bold>Identifica&#231;&#227;o dos pacientes em cada hospital</bold>
    </p>
    <p>Cada coordenador institucional se comprometer&#225; a registrar pacientes no per&#237;odo m&#225;ximo de 12 meses. &#201; fundamental que os pacientes registrados representem de forma fidedigna a popula&#231;&#227;o que &#233; atendida em cada institui&#231;&#227;o. Dessa forma, os pacientes devem ser registrados, na medida da possibilidade log&#237;stica local, de forma consecutiva, com busca ativa nos diferentes setores do Hospital (Sala de Emerg&#234;ncia, Equipes de Medicina Interna e de Cardiologia e Unidades de Tratamento Intensivo). Uma institui&#231;&#227;o que, por exemplo, registrar apenas pacientes de Equipes de Cardiologia estar&#225; ilustrando de forma tendenciosa as caracter&#237;sticas daquela amostra. Ap&#243;s a identifica&#231;&#227;o, conforme os crit&#233;rios de inclus&#227;o acima definidos, os pacientes ser&#227;o convidados a participar do estudo e assinar&#227;o o termo de consentimento informado. Os investigadores locais ent&#227;o preencher&#227;o a Ficha de Registro Individual que estar&#225; dispon&#237;vel em endere&#231;o eletr&#244;nico, acessado atrav&#233;s da p&#225;gina eletr&#244;nica da Sociedade Brasileira de Cardiologia. D&#250;vidas no preenchimento poder&#227;o ser sanadas com o uso do dicion&#225;rio de preenchimento ou por via eletr&#244;nica atrav&#233;s da intranet. Ser&#227;o coletados do prontu&#225;rio dados demogr&#225;ficos, caracter&#237;sticas da IC, outras doen&#231;as associadas e f&#225;rmacos utilizados no manejo dos pacientes durante a interna&#231;&#227;o. Sugere-se que os m&#233;dicos que atendem os pacientes rotineiramente sejam informados em cada institui&#231;&#227;o, atrav&#233;s de uma carta, dos objetivos do estudo, crit&#233;rios de inclus&#227;o e exclus&#227;o e de como os pacientes ser&#227;o arrolados. Deve ficar claro que o objetivo deste registro &#233; exclusivamente descritivo, que n&#227;o ser&#225; influenciado, em hip&#243;tese alguma, o atendimento dos seus pacientes, e que as informa&#231;&#245;es coletadas ser&#227;o utilizadas de forma confidencial, apenas para fins de pesquisa.</p>
    <p>
      <bold>Seguimento dos pacientes</bold>
    </p>
    <p>Os pacientes ser&#227;o reavaliados por consulta m&#233;dica e, no caso da impossibilidade de presen&#231;a, contatados por telefone ap&#243;s 90, 180 e 365 dias da avalia&#231;&#227;o inicial para determina&#231;&#227;o da ocorr&#234;ncia de desfechos cl&#237;nicos e readmiss&#245;es hospitalares.</p>
    <p>
      <bold>Tamanho amostral</bold>
    </p>
    <p>Na primeira fase est&#225; prevista a avalia&#231;&#227;o de 1.200 interna&#231;&#245;es realizadas na rede p&#250;blica e privada. A defini&#231;&#227;o desse tamanho amostral permitir&#225; identificar o objetivo prim&#225;rio descritivo - mortalidade hospitalar (demonstrar taxa de eventos), al&#233;m de respeitar o arrolamento de outros registros internacionais. Como &#233; o caso de outros registros da SBC, existe planejamento para que o Estudo BREATHE seja continuado ap&#243;s 12 meses, arrolando um n&#250;mero maior de pacientes, o que permitir&#225; an&#225;lises futuras e infer&#234;ncias sobre preditores independentes de eventos cl&#237;nicos maiores.</p>
    <p>
      <bold>Desfechos de Interesse</bold>
    </p>
    <p><bold><italic>Desfecho Prim&#225;rio:</italic></bold> Mortalidade total.</p>
    <p><bold><italic>Desfechos Secund&#225;rios:</italic></bold> &#201; a propor&#231;&#227;o de pacientes que recebem interven&#231;&#245;es com benef&#237;cio comprovado demonstrado por diferentes indicadores de qualidade assistencial (por exemplo, uso de inibidores da ECA em dose alvo, uso de betabloqueadores em dose alvo), reinterna&#231;&#245;es por IC, tempo de interna&#231;&#227;o, mortalidade cardiovascular, morte s&#250;bita, qualidade de vida.</p>
    <p>
      <bold>Detalhamento das visitas cl&#237;nicas</bold>
    </p>
    <p><bold><italic>Visita Baseline:</italic></bold> aferi&#231;&#227;o da etiologia da IC, causa da descompensa&#231;&#227;o, exame f&#237;sico e cl&#237;nico, perfil hemodin&#226;mico, fatores de riscos, exames laboratoriais, exames de imagem, medica&#231;&#245;es em uso domiciliar e intra-hospitalar.</p>
    <p><bold><italic>Visita de alta hospitalar:</italic></bold> mensura&#231;&#227;o de indicadores de tratamento do paciente com IC, procedimentos cardiol&#243;gicos intra-hospitalar, medica&#231;&#245;es em uso e exames de imagem.</p>
    <p><bold><italic>Visita de seguimento de 90 dias:</italic></bold> aferi&#231;&#227;o dos eventos cardiovasculares maiores e medica&#231;&#245;es em uso, exames laboratoriais e de imagem.</p>
    <p><bold><italic>Visita de seguimento de 180 dias:</italic></bold> aferi&#231;&#227;o dos eventos cardiovasculares maiores e medica&#231;&#245;es em uso, procedimentos cardiol&#243;gicos, <italic>exames laboratoriais e de imagem</italic>.</p>
    <p><bold><italic>Visita de seguimento de 365 dias:</italic></bold> aferi&#231;&#227;o dos eventos cardiovasculares maiores, medica&#231;&#245;es em uso, procedimentos cardiol&#243;gicos, exames laboratoriais e de imagem.</p>
    <p>
      <bold>An&#225;lise estat&#237;stica prevista</bold>
    </p>
    <p>Vari&#225;veis quantitativas ser&#227;o descritas por m&#233;dia e desvio padr&#227;o na presen&#231;a de distribui&#231;&#227;o normal ou mediana e amplitude interquartil na presen&#231;a de distribui&#231;&#227;o assim&#233;trica. As vari&#225;veis qualitativas ser&#227;o apresentadas por frequ&#234;ncias absolutas (n&#250;mero de pacientes) e relativas (percentuais). Os desfechos, prim&#225;rios e secund&#225;rios, ser&#227;o descritos por percentual global considerando todos os centros e pelo percentual prescrito em cada centro, e ser&#227;o expressos por meio de propor&#231;&#245;es e seus respectivos intervalos de confian&#231;a de 95%. Caso haja grande variabilidade na prescri&#231;&#227;o, uma m&#233;dia ponderada pela vari&#226;ncia em cada centro ser&#225; gerada. Para os modelos de regress&#227;o, vamos relatar os <italic>Odds Ratios</italic> probabilidade [RP] (para regress&#227;o log&#237;stica) ou a rela&#231;&#227;o de risco [RR] (para a regress&#227;o de risco proporcional de Cox), o erro padr&#227;o correspondente, os intervalos de confian&#231;a de 95% e os valores-p associados. Vamos relatar os valores-p at&#233; tr&#234;s casas decimais com valores-p inferiores a 0,001 relatados como p &lt; 0,001. Em todos os testes, usaremos o n&#237;vel de signific&#226;ncia alfa bicaudal = 0,05. O exame de res&#237;duos fornecer&#225; uma avalia&#231;&#227;o das suposi&#231;&#245;es de modelo para as an&#225;lises de regress&#227;o. O teste <italic>Goodness-of-fit</italic> (teste de ajuste) dos modelos ser&#225; realizado utilizando testes Hosmer-Lemeshov apropriados. Vamos realizar todas as an&#225;lises usando Stata vers&#227;o 10.0 (StataCorp. 2007. College Station, TX: StataCorp LP).</p>
    <p>
      <bold>Financiamento</bold>
    </p>
    <p>Este Registro &#233; de propriedade do Departamento de Insufici&#234;ncia Card&#237;aca (DEIC) da Sociedade Brasileira de Cardiologia, utilizando recursos financeiros dedicados a essa finalidade para a sua execu&#231;&#227;o. O Instituto de Ensino e Pesquisa do Hospital do Cora&#231;&#227;o de S&#227;o Paulo (IEP-HCor) foi contratado para operacionalizar a execu&#231;&#227;o deste registro, sob a coordena&#231;&#227;o do DEIC. Os comit&#234;s diretivos deste registro est&#227;o descritos ao final deste artigo.</p>
    <p>
      <bold>Controle de qualidade dos dados</bold>
    </p>
    <p>Todos os centros receber&#227;o treinamento do protocolo e do sistema eletr&#244;nico presencial ou por telefone, estando a equipe de coordena&#231;&#227;o dispon&#237;vel para solucionar d&#250;vidas.</p>
    <p>O controle de qualidade dos dados do estudo se dar&#225; por variadas estrat&#233;gias, como CRF eletr&#244;nico, checagem central de dados, monitoria dos cinco centros com maior n&#250;mero de pacientes recrutados.</p>
    <p>
      <bold>Aspectos &#233;ticos</bold>
    </p>
    <p>O protocolo foi aprovado pelo Comit&#234; de &#201;tica em Pesquisa (CEP) do Hospital do Cora&#231;&#227;o de S&#227;o Paulo, SP (HCor) em 1&#186; de fevereiro de 2011, sob o n&#250;mero de registro 144/2011, e na sequ&#234;ncia, cada centro participante tamb&#233;m teve sua aprova&#231;&#227;o no seu CEP local.</p>
    <p>Todos os pacientes assinar&#227;o o Termo de Consentimento Livre e Esclarecido e o estudo cl&#237;nico ser&#225; conduzido de acordo com os princ&#237;pios da revis&#227;o atual da Declara&#231;&#227;o de Helsinki e das Diretrizes de Boas Pr&#225;ticas Cl&#237;nicas, em sua vers&#227;o mais recente, e da Resolu&#231;&#227;o 196/96. Adicionalmente, obedecer&#225; &#224;s exig&#234;ncias legais locais e regulat&#243;rias do Brasil.</p>
    <p>
      <bold>Pol&#237;tica de publica&#231;&#227;o</bold>
    </p>
    <p>Todas as apresenta&#231;&#245;es do estudo e/ou publica&#231;&#245;es de resultados ter&#227;o como base dados objetivos, verificados e validados previamente, visando garantir a precis&#227;o dos resultados.</p>
    <p>A publica&#231;&#227;o das principais conclus&#245;es da presente pesquisa ter&#225; sua autoria com base nas contribui&#231;&#245;es dos centros participantes. Todos os participantes do registro (investigadores e membros dos comit&#234;s) fizeram uma delega&#231;&#227;o de autoridade antecipada para apresenta&#231;&#227;o e/ou publica&#231;&#227;o dos principais resultados ao DEIC/SBC. Qualquer apresenta&#231;&#227;o ou publica&#231;&#227;o por qualquer participante do ensaio dever&#225; mencionar o estudo e ter a aprova&#231;&#227;o do DEIC/SBC.</p>
    <p>
      <bold>Organiza&#231;&#227;o</bold>
    </p>
    <p>O estudo ser&#225; conduzido e coordenado pelo DEIC/Sociedade Brasileira de Cardiologia (SBC) e pelo Instituto de Ensino e Pesquisa do Hospital do Cora&#231;&#227;o (IEP-HCor).</p>
    <p><bold>Propriedade Intelectual: </bold>DEIC/Sociedade Brasileira de Cardiologia.</p>
    <p>
      <bold>Centros investigadores participantes</bold>
    </p>
    <p>Hospital de Cl&#237;nicas de Porto Alegre/UFRGS, Porto Alegre/RS: Dr. Luis Eduardo Paim Rohde; Hospital S&#227;o Lucas/PUCRS, Porto Alegre/RS: Dr. Luiz Claudio Danzmann; Hospital Universit&#225;rio de Londrina/UEL, Londrina/PR: Dr. Manoel Fernandes Canesin; Hospital Regional Hans Dieter Schmidt, Joinville/SC: Dr. Conrado Roberto Hoffmann Filho; Instituto Dante Pazzanese de Cardiologia, S&#227;o Paulo/SP: Dr. Abilio Augusto Fragata Filho; Total Cor, S&#227;o Paulo/SP: Dr. Antonio Baruzzi; Hospital Auxiliar de Cotox&#243;/InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Antonio Carlos Pereira-Barretto; Hospital das Cl&#237;nicas/Faculdade de Medicina de Botucatu/Unesp, Botucatu/SP: Dra. Beatriz Bojikian Matsubara; Unidade de Miocardiopatia e Doen&#231;as da Aorta InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Charles Mady; Hospital Copa D'Or, Rio de Janeiro/RJ: Dr. Denilson Campos de Albuquerque; Unidade de Insufici&#234;ncia Card&#237;aca - InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Edimar Alcides Bocchi; Hospital Rios D&#180;Or, Rio de Janeiro/RJ: Dr. Elias Pimentel Gouvea; Instituto Dante Pazzanese de Cardiologia, S&#227;o Paulo/SP: Dra. Elizabete Silva dos Santos; Hospital Lifecenter, Belo Horizonte/MG: Dr. Estev&#227;o Lanna Figueiredo; Hospital Escola Alvaro Alvim, Campos dos Goytacazes/RJ: Dr. Felipe Montes Pena; Hospital Vera Cruz, Belo Horizonte/MG: Dr. Fernando Carvalho Neuenschwander; Casa de Sa&#250;de S&#227;o Jos&#233;, Rio de Janeiro/RJ: Dr. Gustavo Luiz Gouvea de Almeida Jr.; Hospital Universit&#225;rio Ant&#244;nio Pedro - UFF, Rio de Janeiro/RJ: Dr. Humberto Villacorta Jr.; Hospital Quinta D'Or, Rio de Janeiro/RJ: Dra. Jacqueline Sampaio; S&#227;o Bernardo Apart Hospital, Colatina/ES: Dr. Jo&#227;o Miguel de Malta Dantas; Instituto Nacional de Cardiologia, Rio de Janeiro/RJ: Dr. Marcelo Imbroinise Bittencourt; Hospital Universit&#225;rio Clementino Fraga Filho/UFRJ, Rio de Janeiro/RJ: Dr. Marcelo Iorio Garcia; Santa Casa de Votuporanga, Votuporanga/SP: Dr. Mauro Esteves Hernandes; Hospital das Cl&#237;nicas de Ribeir&#227;o Preto/ USP-FMRP, Ribeir&#227;o Preto/SP: Dr Marcus Vin&#237;cius Sim&#245;es; Instituto do Cora&#231;&#227;o/HCFMUSP, S&#227;o Paulo/SP: Dr. Mucio Tavares de Oliveira Filho; Hospital Santa Paula, S&#227;o Paulo/SP: Dr. Ot&#225;vio Gebara; Hospital de Base/Famerp, S&#227;o Jos&#233; do Rio Preto/SP: Dr. Paulo Roberto Nogueira; Santa Casa de S&#227;o Paulo, S&#227;o Paulo/SP: Dr. Renato Jorge Alves; Centro de Pesquisa da Cl&#237;nica M&#233;dica e Cardiologia da Unifesp, S&#227;o Paulo/SP: Dr. Renato Delascio Lopes; Hospital Barra D'Or, Rio de Janeiro/RJ: Dr. Ricardo Gusm&#227;o; Hospital Universit&#225;rio Pedro Ernesto/UERJ, Rio de Janeiro/RJ: Dr. Ricardo Mourilhe Rocha; Hospital do Cora&#231;&#227;o, S&#227;o Paulo/SP: Dr. Ricardo Pavanello; Hospital do Cora&#231;&#227;o de Goi&#225;s, Goi&#226;nia/GO: Dr. Aguinaldo Freitas J&#250;nior; Hospital das Cl&#237;nicas da UFMG, Belo Horizonte/MG: Dra. Maria da Consola&#231;&#227;o Vieira Moreira; Hospital Madre Teresa, Belo Horizonte/MG: Dr. Roberto Luiz Marino; Hospital das Cl&#237;nicas UFG, Goi&#226;nia/GO: Dr. Salvador Rassi; Instituto de Cardiologia do Distrito Federal, Bras&#237;lia/DF: Dr. Carlos V. Nascimento; Hospital Universit&#225;rio S&#227;o Jos&#233;/FCMMG, Belo Horizonte/MG: Dr. Sidney Ara&#250;jo S&#227;o Jos&#233;; Funda&#231;&#227;o Bahiana de Cardiologia, Salvador/BA: Dr. Alvaro Rabelo; S&#227;o Lucas M&#233;dico Hospitalar, Aracaju/SE: Dr. Antonio Carlos Sobral Sousa; Instituto Cardiopulmonar, Salvador/BA: Dr. Eduardo Darz&#233;; Funda&#231;&#227;o Benefic&#234;ncia Hospital de Cirurgia/Hospital do Cora&#231;&#227;o, Aracaju/SE: Dr. Fabio Serra Silveira; Hospital Santa Izabel, Salvador/BA: Dr. Gilson Soares Feitosa; Hospital Espanhol, Salvador/BA: Dr. Fabio Villas-Boas; Hospital de Messejana, Fortaleza/CE: Dr. Jo&#227;o David de Souza Neto; Hospital Universit&#225;rio Presidente Dutra/UFMA, S&#227;o Lu&#237;s/MA: Dr. Jos&#233; Albuquerque de Figueiredo Neto; Hospital da Cidade, Salvador/BA: Dr. Marcelo Silveira Teixeira; Real Hospital Portugu&#234;s de Benefic&#234;ncia em Pernambuco, Recife/PE: Dra. Silvia Marinho Martins; Hospital Universit&#225;rio Professor Alberto Antunes HUPAA, Macei&#243;/AL: Dra. Maria Alayde Mendon&#231;a da Silva; Hospital Universit&#225;rio Jo&#227;o de Barros Barreto - UFPA, Bel&#233;m/PA: Dr. Eduardo Costa; Funda&#231;&#227;o Hospital de Cl&#237;nicas Gaspar Vianna, Bel&#233;m/PA: Dr. Helder Jos&#233; Lima Reis.</p>
    <p><bold>Comit&#234; Diretivo BREATHE: </bold>Denilson Campos de Albuquerque, Jo&#227;o David de Souza Neto, Fernando Bacal, Ot&#225;vio Berwanger, H&#233;lio Penna Guimar&#227;es.</p>
    <p><bold>Comit&#234; Diretivo SBC:</bold> Fernando Bacal, Ot&#225;vio Berwanger, Luiz Alberto Piva de Matos, Jadelson Andrade.</p>
    <p><bold>Equipe do Centro Coordenador Nacional: </bold>H&#233;lio Penna Guimar&#227;es, Karina Normilio da Silva, Katia Cristina Leite, Juliana Trench Ciampone, Sabrina Bernardez Pereira, Matheus de Oliveira Abreu.</p>
    <p><bold>Propriedade Intelectual: </bold>DEIC/Sociedade Brasileira de Cardiologia.</p>
    <p>
      <bold>Refer&#234;ncias</bold>
    </p>
    <p content-type="ref-to-delete">1. Bocchi EA, Marcondes-Braga FG, Ayub-Ferreira SM, Rohde LE, Oliveira WA, Almeida DR, et al; Sociedade Brasileira de Cardiologia. III Diretriz brasileira de insufici&#234;ncia card&#237;aca cr&#244;nica. Arq Bras Cardiol. 2009;93(1 supl.1):1-71. </p>
    <p content-type="ref-to-delete">2. Bocchi EA, Marcondes-Braga FG, Bacal F, Ferraz AS, Albuquerque D, Rodrigues D, et al; Sociedade Brasileira de Cardiologia. Atualiza&#231;&#227;o da Diretriz brasileira de insufici&#234;ncia card&#237;aca cr&#244;nica - 2012. Arq Bras Cardiol. 2012;98(1 supl. 1):1-33. </p>
    <p content-type="ref-to-delete">3. American Heart Association. 2004 Heart Disease and Stroke Statistical update. [Accessed on 2004 Feb 02]. Available from: <ext-link ext-link-type="uri" xlink:href="http://www.americanheart.org/statistics">http://www.americanheart.org/statistics</ext-link> </p>
    <p content-type="ref-to-delete">4. Krumholz HM, Parent EM, Tu N, Vaccarino V, Wang Y, Radford MJ, et al. Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. Arch Intern Med. 1997;157(1):99-104. </p>
    <p content-type="ref-to-delete">5. Montera MW, Almeida RA, Tinoco EM, Rocha RM, Moura LZ, R&#233;a-Neto A, et al; Sociedade Brasileira de Cardiologia. II Diretriz brasileira de insufici&#234;ncia card&#237;aca aguda. Arq Bras Cardiol. 2009;93(3 supl.3):1-65. </p>
    <p content-type="ref-to-delete">6. Albanesi Filho FA. Insufici&#234;ncia card&#237;aca no Brasil. Arq Bras Cardiol. 1998;71(4):561-2. </p>
    <p content-type="ref-to-delete">7. Stewart S, Blue L, Capewell S, Horowitz JD, McMurray JJ. Poles apart, but are they the same? A comparative study of Australia and Scottish patients with chronic heart failure. Eur J Heart Fail. 2001;3(2):249-55. </p>
    <p content-type="ref-to-delete">8. Tavares LR, Victer H, Linhares JM, de Barros CM, Oliveira MV, Pacheco LC, et al. Epidemiologia da insufici&#234;ncia card&#237;aca avan&#231;ada em Niter&#243;i- Projeto EPICA Niter&#243;i. Arq Bras Cardiol. 2004;82(2):125-8,121-4. </p>
    <p content-type="ref-to-delete">9. Tavares L, Silva GP, Pereira SB, Souza G, Pozam R, Victer H, et al. Co-morbidades e fatores de descompensa&#231;&#227;o dos pacientes internados por insufici&#234;ncia card&#237;aca descompesada na cidade de Niter&#243;i. In: 57 Congresso Brasileiro de Cardiologia, S&#227;o Paulo, 21-24 set.; 2002.  Arq Bras Cardiol. 2002;78(supl 4):35,79. </p>
    <p content-type="ref-to-delete">10. Marantz PR, Tobin JN, Wassertheil-Smoller S, Steingart RM, Wexler JP, Budner N, et al. The relationship between left ventricular systolic function and congestive heart failure diagnosed by clinical criteria. Circulation. 1988;77(3):607-12. </p>
    <p>
      <fn id="end" fn-type="corresp">
        <label>
          <bold>Correspond&#234;ncia:</bold>
        </label>
        <p> Denilson Albuquerque </p>
        <p> Rua Volunt&#225;rios da P&#225;tria 445 Sala 1402, Botafogo </p>
        <p> CEP 24240-670, Rio de Janeiro - RJ - Brasil </p>
        <p> E-mail: </p>
        <p>
          <email xlink:href="albuquerque@cardiol.br">albuquerque@cardiol.br</email>
        </p>
      </fn>
    </p>
    <p>Artigo recebido em 01/03/13; revisado em 06/03/13; aceito em 28/03/13.</p>
  </body>
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  </back>
  <sub-article article-type="translation" id="TRen" xml:lang="en">
    <front-stub>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Special Article</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title xml:lang="en">Rationale and design: BREATHE registry - I brazilian registry of heart failure</article-title>
      </title-group>
      <abstract xml:lang="en">
        <p>BACKGROUND: Several local registries have sought to individually depict clinical characteristics of patients hospitalized with heart failure (HF) in Brazilian hospitals and communities. Overall, the analysis of these data suggests that there are important differences in etiology, decompensation factors, treatment and prognosis of patients with HF in different Brazilian regions. OBJECTIVES: To evaluate the demographic, clinical and prognostic characteristics of 1,200 patients admitted with a clinical diagnosis of decompensated HF in a group of 60 hospitals representative of the different Brazilian regions. METHODS: Transversal observational study (registry) with a longitudinal twelve-month follow-up (admission consultations, hospital discharge, three months, six months and twelve months after inclusion), in which patients admitted to public and private hospitals clinical with a primarily defined HF diagnosis will be studied. RESULTS: The results will be shown soon after data collection completion, quality assessment and statistical analysis. CONCLUSIONS: The results of this multicenter registry will allow for a more appropriate planning of financial, technological and personal resource supply for the health care area, as well as the planning of more effective preventive measures in decompensated HF.</p>
      </abstract>
      <kwd-group xml:lang="en">
        <kwd>Heart Failure</kwd>
        <kwd>Medical Records</kwd>
        <kwd>Inpatients</kwd>
        <kwd>Brazil</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <p>
        <bold>SPECIAL ARTICLE</bold>
      </p>
      <p>
        <bold>Rationale and design - BREATHE registry - I brazilian registry of heart failure</bold>
      </p>
      <p>
        <bold>Em nome dos Investigadores do BREATHE</bold>
      </p>
      <p>Sociedade Brasileira de Cardiologia - Departamento de Insufici&#234;ncia Card&#237;aca (DEIC)</p>
      <p>
        <xref ref-type="corresp" rid="end-body2">Mailing Address</xref>
      </p>
      <p>
        <bold>ABSTRACT</bold>
      </p>
      <p><bold>BACKGROUND:</bold> Several local registries have sought to individually depict clinical characteristics of patients hospitalized with heart failure (HF) in Brazilian hospitals and communities. Overall, the analysis of these data suggests that there are important differences in etiology, decompensation factors, treatment and prognosis of patients with HF in different Brazilian regions.</p>
      <p><bold>OBJECTIVES:</bold> To evaluate the demographic, clinical and prognostic characteristics of 1,200 patients admitted with a clinical diagnosis of decompensated HF in a group of 60 hospitals representative of the different Brazilian regions.</p>
      <p><bold>METHODS:</bold> Transversal observational study (registry) with a longitudinal twelve-month follow-up (admission consultations, hospital discharge, three months, six months and twelve months after inclusion), in which patients admitted to public and private hospitals clinical with a primarily defined HF diagnosis will be studied.</p>
      <p><bold>RESULTS:</bold> The results will be shown soon after data collection completion, quality assessment and statistical analysis.</p>
      <p><bold>CONCLUSIONS:</bold> The results of this multicenter registry will allow for a more appropriate planning of financial, technological and personal resource supply for the health care area, as well as the planning of more effective preventive measures in decompensated HF.</p>
      <p><bold>Keywords:</bold> Heart Failure; Medical Records; Inpatients; Brazil.</p>
      <p>
        <bold>Introduction</bold>
      </p>
      <p>Heart failure (HF) is a complex systemic clinical syndrome, defined as cardiac dysfunction that causes inadequate blood supply to meet the metabolic tissue needs in the presence of normal venous return, or do so only with elevated filling pressures. The hemodynamic alterations commonly found in HF involve inadequate response of cardiac output and elevated pulmonary and systemic venous pressures<sup>1,2</sup>. HF is a major cause of mortality in Brazil and is responsible for a high number of hospital admissions per year (data from the Brazilian Unified Health System Database - DataSUS, 2003). In the United States, HF affects more than five million people and nearly 550,000 new cases occur annually<sup>3</sup>; it is estimated that its incidence affects 10/1,000 people after 65 years of age.</p>
      <p>In Brazil and in the rest of the world, there is consistent evidence on the high rate of hospital admissions and emergency room visits due to clinical complications associated with the disease. Among patients older than 70 years admitted for HF, 60% are readmitted within 90 days<sup>4-6</sup>.</p>
      <p>The most comprehensive picture of the situation of hospitalizations for HF in Brazil can be obtained by analyzing DataSUS records with the inherent limitations of an administrative database<sup>6</sup>. Data for the year 1997 show that HF was a very frequent cause of hospitalization (3.6% of all admissions and 37% of circulatory system hospitalizations); in addition to causing high rates of in-hospital mortality (6.4 % in 1997). In that year, costs related exclusively to HF admissions represented 4.7% (or approximately 75 million dollars) of the money spent on hospital admissions through SUS.</p>
      <p>Data from DataSUS for the year 2007 showed a reduction in the number of hospitalizations in the last ten years, regardless of age range, with increased mortality rate<sup>5,6</sup>.</p>
      <p>Several local registries have sought to individually depict clinical characteristics of patients hospitalized with heart failure (HF) in Brazilian hospitals and communities. Overall, the analysis of these data suggests that there are important differences in etiology, decompensation factors, treatment and prognosis of patients with HF in different Brazilian regions<sup>7-9</sup>.</p>
      <p>
        <bold>Methods</bold>
      </p>
      <p>The Registry represents a project of current clinical practice documentation regarding the care of decompensated heart failure in Brazil, aimed at identifying the incorporation of evidence into clinical practice in the treatment of this disease, involving public and private hospitals. Additionally, a longitudinal follow-up of these patients will be carried out, until hospital discharge and mortality at 90, 180 and 365 days.</p>
      <p>
        <bold>Design</bold>
      </p>
      <p>This is a transversal observational study (registry) with longitudinal follow-up.</p>
      <p>
        <bold>Hospital selection</bold>
      </p>
      <p>The hospitals, both public and private, which will participate in the Decompensated Heart Failure Registry of DEIC will be chosen by an investigator committee according to rules defined <italic>a priori</italic>. A fixed number of patients will be allocated for each of the five regions of the country who will participate in the registry. Each selected hospital will have an institutional coordinator who will be responsible for registry of data on consecutive patients with a clinical diagnosis of IC in up to 12 months.</p>
      <p>
        <bold>Inclusion and exclusion criteria</bold>
      </p>
      <p>Patients admitted to public and private hospitals with a primarily defined HF diagnosis will be studied. The criteria used to diagnose HF have been previously described, validated and applied in our country in similar studies in the past <xref ref-type="table" rid="tab01-body2">(Table 1</xref>)<sup>10</sup>. To be included in the study, patients must have a score &gt; 7, attaining a definitive HF diagnosis.</p>
      <table-wrap id="tab01-body2">
        <graphic xlink:href="1678-4170-abc-100-05-0390-30093-gt01-en.jpg"/></table-wrap>
      <p>Patients who underwent myocardial revascularization procedures (angioplasty or surgery) in the last month and patients with signs of HF secondary to a sepsis picture will be excluded.</p>
      <p>
        <bold>Patient identification at each hospital</bold>
      </p>
      <p>Each institutional coordinator will be responsible to enroll patients during a maximum period of 12 months. It is essential that the registry patients reliably represent the population treated at each institution. Thus, patients must be registered consecutively, according to the possibility of local logistics, following an active search in different sectors of the Hospital (Emergency Room, Internal Medicine groups and Cardiology and Intensive Care Units). An institution, for instance, which registers only patients from the Cardiology Team will be demonstrating a biased depiction of the sample's characteristics.</p>
      <p>After identification, according to the above defined the inclusion criteria, patients will be invited to participate in the study and sign the informed consent form. The local researchers will then fill the Individual Registration Form that will be available in an electronic address, accessed through the Brazilian Society of Cardiology website. Questions that arise during the filling of forms can be answered with the use of online dictionary or electronically through the intranet.</p>
      <p>Demographic data, as well as data on HF characteristics, associated diseases and drugs used in patient management during hospitalization will be collected. It is suggested that physicians routinely in charge of patients be informed through a letter, at each institution, of the study objectives, inclusion and exclusion criteria and how patients will be enrolled. It should be clear that the aim of this registry is exclusively descriptive, will not influence patient care in any way and that the collected information will be used confidentially, solely for research purposes.</p>
      <p>
        <bold>Patient follow-up</bold>
      </p>
      <p>Patients will be reassessed through medical consultation and, when unable to return for reassessment, will be contacted by telephone after 90, 180 and 365 days of the initial evaluation to determine the occurrence of clinical outcomes and hospital readmissions.</p>
      <p>
        <bold>Sample size</bold>
      </p>
      <p>In the first phase, 1,200 hospitalizations in public and private hospitals are expected to be evaluated. The sample size definition will identify the primary descriptive goal - hospital mortality (demonstrate event rate), in addition to respecting the enrollment of other international registries. As is the case with other SBC registries, the BREATHE study aims to be continued after the 12-month period, enrolling a greater number of patients, which will allow future analyses and inferences on independent predictors of major clinical events.</p>
      <p>
        <bold>Outcomes of interest</bold>
      </p>
      <p><bold><italic>Primary outcome:</italic></bold> Overall mortality.</p>
      <p><bold><italic>Secondary Outcomes:</italic></bold> It is the proportion of patients undergoing interventions with proven benefits demonstrated by several indicators of quality of care (e.g., use of ACE inhibitors in target dose, use of beta-blockers in target dose), rehospitalization due to HF, length of hospital stay, cardiovascular mortality, sudden death, quality of life.</p>
      <p>
        <bold>Clinical visit characteristics</bold>
      </p>
      <p><bold><italic>Baseline Visit:</italic></bold> assessment of HF etiology, cause of decompensation, physical and clinical examination, hemodynamic profile, risk factors, laboratory tests, imaging tests, medications for use at home and during hospitalization.</p>
      <p><bold><italic>Hospital discharge visit:</italic></bold> assessment of treatment indicators in HF patients, in-hospital cardiac procedures, current medications and imaging tests.</p>
      <p><bold><italic>90-day follow-up visit:</italic></bold> assessment of major cardiovascular events and current medications, laboratory and imaging tests.</p>
      <p><bold><italic>180-day follow-up visit:</italic></bold> assessment of major cardiovascular events and current medications, cardiological procedures, laboratory and imaging tests.</p>
      <p><bold><italic>365-day follow-up visit:</italic></bold> assessment of major cardiovascular events and current medications, cardiological procedures, laboratory and imaging tests.</p>
      <p>
        <bold>Predicted statistical analysis</bold>
      </p>
      <p>Quantitative variables will be expressed as mean and standard deviation in the presence of normal distribution or median and interquartile range in the presence of asymmetric distribution. Qualitative variables are expressed as absolute (number of patients) and relative (percentage) frequencies. Primary and secondary outcomes will be described by overall percentage, considering all the centers as well as by the percentage prescribed in each center and will be expressed by proportions and their respective 95% confidence intervals.</p>
      <p>In case of great variability in the prescription, a variance-weighted mean will be generated in each center. For the regression models, the odds ratios [OR] (for logistic regression) or hazard ratio [HR] (for Cox proportional hazard regression), the corresponding standard error, the 95% confidence intervals and the associated p-values will be reported. P-values will be reported up to three decimal places with p-values &lt; 0.001 reported as p &lt; 0.001. The two-tailed alpha significance level = 0.05 will be used in all tests. Residual analysis will provide an assessment of model assumptions for the regression analyses. The goodness-of-fit test of the models will be performed using appropriate Hosmer-Lemeshow Tests. All analyzes will be performed using Stata software, relaease 10.0 (StataCorp. 2007. College Station, TX: StataCorp LP).</p>
      <p>
        <bold>Financial support</bold>
      </p>
      <p>This Registry is owned by the Department of Heart Failure (DEIC) of the Brazilian Society of Cardiology, using funds dedicated to this purpose for its implementation. The Instituto de Ensino e Pesquisa do Hospital do Cora&#231;&#227;o de S&#227;o Paulo (IEP-HCor) was employed to operationalize the performance of this registry under the coordination of DEIC. The directive committees of this registry are described at the end of this article.</p>
      <p>
        <bold>Data quality control</bold>
      </p>
      <p>All centers will receive protocol and electronic system training in person or by phone and the coordination team will be available to answer any questions that might arise.</p>
      <p>The study data quality control will be performed through several strategies, such as electronic CRF, central data checking, monitoring of the five centers with the highest numbers of enrolled patients.</p>
      <p>
        <bold>Ethical aspects</bold>
      </p>
      <p>The protocol was approved by the Research Ethics Committee (REC) of Hospital do Cora&#231;&#227;o de S&#227;o Paulo, SP (HCor), on the 1<sup>st</sup> of February, 2011, under registration number 144/2011 and subsequently, each participating center was also approved locally.</p>
      <p>All patients will sign the Free and Informed Consent Form and the clinical trial will be carried out in accordance with the principles of the current revision of the Declaration of Helsinki and Good Clinical Practice Guidelines, in its latest version, and according to Resolution 196/96. Additionally, it will follow the local legal and regulatory requirements of Brazil.</p>
      <p>
        <bold>Publication policy</bold>
      </p>
      <p>All study presentations and/or result publications will be based on objective data, verified and validated beforehand, to ensure result accuracy.</p>
      <p>The publication of the main findings will have authorship based on the contributions of the participating centers. All registry participants (researchers and committee members) have previously delegated the authority for the presentation and/ or publication of the main results to DEIC/ SBC. Any presentation or publication by any participant of the trial should mention the study and have the approval of DEIC / SBC.</p>
      <p>
        <bold>Organization</bold>
      </p>
      <p>The study will be carried out and coordinated by DEIC / Brazilian Society of Cardiology (SBC) and the Instituto de Ensino e Pesquisa do Hospital do Cora&#231;&#227;o (IEP-HCor).</p>
      <p><bold>Intellectual Property: </bold>DEIC/Sociedade Brasileira de Cardiologia.</p>
      <p>
        <bold>Participating Investigation Centers:</bold>
      </p>
      <p>Hospital de Cl&#237;nicas de Porto Alegre/UFRGS, Porto Alegre/RS: Dr. Luis Eduardo Paim Rohde; Hospital S&#227;o Lucas/PUCRS, Porto Alegre/RS: Dr. Luiz Claudio Danzmann; Hospital Universit&#225;rio de Londrina/UEL, Londrina/PR: Dr. Manoel Fernandes Canesin; Hospital Regional Hans Dieter Schmidt, Joinville/SC: Dr. Conrado Roberto Hoffmann Filho; Instituto Dante Pazzanese de Cardiologia, S&#227;o Paulo/SP: Dr. Abilio Augusto Fragata Filho; Total Cor, S&#227;o Paulo/SP: Dr. Antonio Baruzzi; Hospital Auxiliar de Cotox&#243;/InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Antonio Carlos Pereira-Barretto; Hospital das Cl&#237;nicas/Faculdade de Medicina de Botucatu/Unesp, Botucatu/SP: Dra. Beatriz Bojikian Matsubara; Unidade de Miocardiopatia e Doen&#231;as da Aorta InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Charles Mady; Hospital Copa D'Or, Rio de Janeiro/RJ: Dr. Denilson Campos de Albuquerque; Unidade de Insufici&#234;ncia Card&#237;aca - InCor/HCFMUSP, S&#227;o Paulo/SP: Dr. Edimar Alcides Bocchi; Hospital Rios D&#180;Or, Rio de Janeiro/RJ: Dr. Elias Pimentel Gouvea; Instituto Dante Pazzanese de Cardiologia, S&#227;o Paulo/SP: Dra. Elizabete Silva dos Santos; Hospital Lifecenter, Belo Horizonte/MG: Dr. Estev&#227;o Lanna Figueiredo; Hospital Escola Alvaro Alvim, Campos dos Goytacazes/RJ: Dr. Felipe Montes Pena; Hospital Vera Cruz, Belo Horizonte/MG: Dr. Fernando Carvalho Neuenschwander; Casa de Sa&#250;de S&#227;o Jos&#233;, Rio de Janeiro/RJ: Dr. Gustavo Luiz Gouvea de Almeida Jr.; Hospital Universit&#225;rio Ant&#244;nio Pedro - UFF, Rio de Janeiro/RJ: Dr. Humberto Villacorta Jr.; Hospital Quinta D'Or, Rio de Janeiro/RJ: Dra. Jacqueline Sampaio; S&#227;o Bernardo Apart Hospital, Colatina/ES: Dr. Jo&#227;o Miguel de Malta Dantas; Instituto Nacional de Cardiologia, Rio de Janeiro/RJ: Dr. Marcelo Imbroinise Bittencourt; Hospital Universit&#225;rio Clementino Fraga Filho/UFRJ, Rio de Janeiro/RJ: Dr. Marcelo Iorio Garcia; Santa Casa de Votuporanga, Votuporanga/SP: Dr. Mauro Esteves Hernandes; Hospital das Cl&#237;nicas de Ribeir&#227;o Preto/ USP-FMRP, Ribeir&#227;o Preto/SP: Dr Marcus Vin&#237;cius Sim&#245;es; Instituto do Cora&#231;&#227;o/HCFMUSP, S&#227;o Paulo/SP: Dr. Mucio Tavares de Oliveira Filho; Hospital Santa Paula, S&#227;o Paulo/SP: Dr. Ot&#225;vio Gebara; Hospital de Base/Famerp, S&#227;o Jos&#233; do Rio Preto/SP: Dr. Paulo Roberto Nogueira; Santa Casa de S&#227;o Paulo, S&#227;o Paulo/SP: Dr. Renato Jorge Alves; Centro de Pesquisa da Cl&#237;nica M&#233;dica e Cardiologia da Unifesp, S&#227;o Paulo/SP: Dr. Renato Delascio Lopes; Hospital Barra D'Or, Rio de Janeiro/RJ: Dr. Ricardo Gusm&#227;o; Hospital Universit&#225;rio Pedro Ernesto/UERJ, Rio de Janeiro/RJ: Dr. Ricardo Mourilhe Rocha; Hospital do Cora&#231;&#227;o, S&#227;o Paulo/SP: Dr. Ricardo Pavanello; Hospital do Cora&#231;&#227;o de Goi&#225;s, Goi&#226;nia/GO: Dr. Aguinaldo Freitas J&#250;nior; Hospital das Cl&#237;nicas da UFMG, Belo Horizonte/MG: Dra. Maria da Consola&#231;&#227;o Vieira Moreira; Hospital Madre Teresa, Belo Horizonte/MG: Dr. Roberto Luiz Marino; Hospital das Cl&#237;nicas UFG, Goi&#226;nia/GO: Dr. Salvador Rassi; Instituto de Cardiologia do Distrito Federal, Bras&#237;lia/DF: Dr. Carlos V. Nascimento; Hospital Universit&#225;rio S&#227;o Jos&#233;/FCMMG, Belo Horizonte/MG: Dr. Sidney Ara&#250;jo S&#227;o Jos&#233;; Funda&#231;&#227;o Bahiana de Cardiologia, Salvador/BA: Dr. Alvaro Rabelo; S&#227;o Lucas M&#233;dico Hospitalar, Aracaju/SE: Dr. Antonio Carlos Sobral Sousa; Instituto Cardiopulmonar, Salvador/BA: Dr. Eduardo Darz&#233;; Funda&#231;&#227;o Benefic&#234;ncia Hospital de Cirurgia/Hospital do Cora&#231;&#227;o, Aracaju/SE: Dr. Fabio Serra Silveira; Hospital Santa Izabel, Salvador/BA: Dr. Gilson Soares Feitosa; Hospital Espanhol, Salvador/BA: Dr. Fabio Villas-Boas; Hospital de Messejana, Fortaleza/CE: Dr. Jo&#227;o David de Souza Neto; Hospital Universit&#225;rio Presidente Dutra/UFMA, S&#227;o Lu&#237;s/MA: Dr. Jos&#233; Albuquerque de Figueiredo Neto; Hospital da Cidade, Salvador/BA: Dr. Marcelo Silveira Teixeira; Real Hospital Portugu&#234;s de Benefic&#234;ncia em Pernambuco, Recife/PE: Dra. Silvia Marinho Martins; Hospital Universit&#225;rio Professor Alberto Antunes HUPAA, Macei&#243;/AL: Dra. Maria Alayde Mendon&#231;a da Silva; Hospital Universit&#225;rio Jo&#227;o de Barros Barreto - UFPA, Bel&#233;m/PA: Dr. Eduardo Costa; Funda&#231;&#227;o Hospital de Cl&#237;nicas Gaspar Vianna, Bel&#233;m/PA: Dr. Helder Jos&#233; Lima Reis.</p>
      <p><bold>BREATHE Directive Committee:</bold> Denilson Campos de Albuquerque, Jo&#227;o David de Souza Neto, Fernando Bacal, Ot&#225;vio Berwanger, H&#233;lio Penna Guimar&#227;es.</p>
      <p><bold>SBC Directive Committee:</bold> Fernando Bacal, Ot&#225;vio Berwanger, Luiz Alberto Piva de Matos, Jadelson Andrade.</p>
      <p><bold>National Coordinator Center Team:</bold> H&#233;lio Penna Guimar&#227;es, Karina Normilio da Silva, Katia Cristina Leite, Juliana Trench Ciampone, Sabrina Bernardez Pereira, Matheus de Oliveira Abreu.</p>
      <p><bold>Intellectual Property:</bold> DEIC/Sociedade Brasileira de Cardiologia.</p>
      <p>
        <bold>References</bold>
      </p>
      <p content-type="ref-to-delete">1. Bocchi EA, Marcondes-Braga FG, Ayub-Ferreira SM, Rohde LE, Oliveira WA, Almeida DR, et al; Sociedade Brasileira de Cardiologia. III Diretriz brasileira de insufici&#234;ncia card&#237;aca cr&#244;nica. Arq Bras Cardiol. 2009;93(1 supl.1):1-71. </p>
      <p content-type="ref-to-delete">2. Bocchi EA, Marcondes-Braga FG, Bacal F, Ferraz AS, Albuquerque D, Rodrigues D, et al; Sociedade Brasileira de Cardiologia. Atualiza&#231;&#227;o da Diretriz brasileira de insufici&#234;ncia card&#237;aca cr&#244;nica - 2012. Arq Bras Cardiol. 2012;98(1 supl. 1):1-33. </p>
      <p content-type="ref-to-delete">3. American Heart Association. 2004 Heart Disease and Stroke Statistical update. [Accessed on 2004 Feb 02]. Available from: <ext-link ext-link-type="uri" xlink:href="http://www.americanheart.org/statistics">http://www.americanheart.org/statistics</ext-link> </p>
      <p content-type="ref-to-delete">4. Krumholz HM, Parent EM, Tu N, Vaccarino V, Wang Y, Radford MJ, et al. Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. Arch Intern Med. 1997;157(1):99-104. </p>
      <p content-type="ref-to-delete">5. Montera MW, Almeida RA, Tinoco EM, Rocha RM, Moura LZ, R&#233;a-Neto A, et al; Sociedade Brasileira de Cardiologia. II Diretriz brasileira de insufici&#234;ncia card&#237;aca aguda. Arq Bras Cardiol. 2009;93(3 supl.3):1-65. </p>
      <p content-type="ref-to-delete">6. Albanesi Filho FA. Insufici&#234;ncia card&#237;aca no Brasil. Arq Bras Cardiol. 1998;71(4):561-2. </p>
      <p content-type="ref-to-delete">7. Stewart S, Blue L, Capewell S, Horowitz JD, McMurray JJ. Poles apart, but are they the same? A comparative study of Australia and Scottish patients with chronic heart failure. Eur J Heart Fail. 2001;3(2):249-55. </p>
      <p content-type="ref-to-delete">8. Tavares LR, Victer H, Linhares JM, de Barros CM, Oliveira MV, Pacheco LC, et al. Epidemiologia da insufici&#234;ncia card&#237;aca avan&#231;ada em Niter&#243;i- Projeto EPICA Niter&#243;i. Arq Bras Cardiol. 2004;82(2):125-8,121-4. </p>
      <p content-type="ref-to-delete">9. Tavares L, Silva GP, Pereira SB, Souza G, Pozam R, Victer H, et al. Co-morbidades e fatores de descompensa&#231;&#227;o dos pacientes internados por insufici&#234;ncia card&#237;aca descompesada na cidade de Niter&#243;i. In: 57 Congresso Brasileiro de Cardiologia, S&#227;o Paulo, 21-24 set.; 2002.  Arq Bras Cardiol. 2002;78(supl 4):35,79. </p>
      <p>10. Marantz PR, Tobin JN, Wassertheil-Smoller S, Steingart RM, Wexler JP, Budner N, et al. The relationship between left ventricular systolic function and congestive heart failure diagnosed by clinical criteria. Circulation. 1988;77(3):607-12.      </p>
      <p>
        <fn id="end-body2" fn-type="corresp">
          <label>
            <bold>Mailing Address:</bold>
          </label>
          <p> Denilson Albuquerque</p>
          <p> Rua Volunt&#225;rios da P&#225;tria 445 Sala 1402, Botafogo</p>
          <p> Postal Code 24240-670, Rio de Janeiro - RJ - Brazil</p>
          <p> E-mail: </p>
          <p>
            <email xlink:href="albuquerque@cardiol.br">albuquerque@cardiol.br</email>
          </p>
        </fn>
      </p>
      <p>Manuscript received March 01, 2013, revised March 06, 2013, accepted March 28, 2013.</p>
    </body>
  </sub-article>
</article>
