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spelling Holanda, Marcelo TeixeiraMediano, Mauro Felippe FelixHasslocher-Moreno, Alejandro MarcelXavier, Sérgio SallesSaraiva, Roberto MagalhãesSousa, Andrea SilvestreMaciel, Erica RodriguesCarneiro, Fernanda MartinsSilva, Paula Simplicio daSangenis, Luiz Henrique CondeVeloso, Henrique HortaCardoso, Claudia Santos de AguiarBonecini-Almeida, Maria da GloriaSouza, Andreia LamogliaRoma, Eric HenriqueAzevedo, Marcos JoséPereira-Silva, Fernanda Sant'AnaPimentel, Luis OtavioMendes, Marcelo OliveiraGarzoni, Luciana RibeiroGonzaga, Beatriz M. S.Carvalho, Anna Cristina CalçadaBrasil, Pedro Emmanuel Alvarenga AmericanoSilva, Gilberto Marcelo Sperandio daAraújo-Jorge, Tania Cremonini2019-07-12T13:15:15Z2019-07-12T13:15:15Z2018HOLANDA, Marcelo Teixeira et al. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials, v. 19, p. 1-3, 2018.1745-6215https://www.arca.fiocruz.br/handle/icict/3402010.1186/s13063-018-2889-81745-6215engBMCA protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Several studies evaluating clinical forms of chronic Chagas disease show that about one-third of patients present cardiac involvement. Heart failure, sudden death and cardioembolic stroke are the main mechanisms of death in Chagas heart disease. The impact of specific etiologic treatment on the prognosis of patients with chronic Chagas heart disease is very limited regardless of the presence or absence of heart failure. Patients with symptomatic Chagas heart disease present serum selenium (Se) levels lower than patients without Chagas heart disease. Moreover, Se supplementation in animal models showed promising results. The aim of this trial is to estimate the effect of Se treatment on prevention of heart disease progression in patients with Chagas cardiomyopathy. However, we had to introduce some protocol modifications in order to keep trial feasibility, as follows: the primary outcome was restricted to left ventricular ejection fraction as a continuous variable, excluding disease progression; the follow-up period was decreased from 5 years to 1 year, an adjustment that might increase the participation rate of our study; the superior age limit was increased from 65 to 75 years; and diabetes mellitus was no longer considered an exclusion criterion. All of these protocol modifications were extensively debated by the research team enrolled in the design, recruitment and conduction of the clinical trial to guarantee a high scientific quality.Chagas cardiomyopathyChagas diseaseClinical trialSeleniumTrypanosoma cruziinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83104https://www.arca.fiocruz.br/bitstream/icict/34020/1/license.txt79178e5f2a0eb066867a274556814938MD51ORIGINALve_Holanda_Marcelo_etal_INI_2018.pdfve_Holanda_Marcelo_etal_INI_2018.pdfapplication/pdf526580https://www.arca.fiocruz.br/bitstream/icict/34020/2/ve_Holanda_Marcelo_etal_INI_2018.pdfedc435c6ada216c55babb4408ef24b68MD52TEXTve_Holanda_Marcelo_etal_INI_2018.pdf.txtve_Holanda_Marcelo_etal_INI_2018.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
title A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
spellingShingle A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
Holanda, Marcelo Teixeira
Chagas cardiomyopathy
Chagas disease
Clinical trial
Selenium
Trypanosoma cruzi
title_short A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
title_full A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
title_fullStr A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
title_full_unstemmed A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
title_sort A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
author Holanda, Marcelo Teixeira
author_facet Holanda, Marcelo Teixeira
Mediano, Mauro Felippe Felix
Hasslocher-Moreno, Alejandro Marcel
Xavier, Sérgio Salles
Saraiva, Roberto Magalhães
Sousa, Andrea Silvestre
Maciel, Erica Rodrigues
Carneiro, Fernanda Martins
Silva, Paula Simplicio da
Sangenis, Luiz Henrique Conde
Veloso, Henrique Horta
Cardoso, Claudia Santos de Aguiar
Bonecini-Almeida, Maria da Gloria
Souza, Andreia Lamoglia
Roma, Eric Henrique
Azevedo, Marcos José
Pereira-Silva, Fernanda Sant'Ana
Pimentel, Luis Otavio
Mendes, Marcelo Oliveira
Garzoni, Luciana Ribeiro
Gonzaga, Beatriz M. S.
Carvalho, Anna Cristina Calçada
Brasil, Pedro Emmanuel Alvarenga Americano
Silva, Gilberto Marcelo Sperandio da
Araújo-Jorge, Tania Cremonini
author_role author
author2 Mediano, Mauro Felippe Felix
Hasslocher-Moreno, Alejandro Marcel
Xavier, Sérgio Salles
Saraiva, Roberto Magalhães
Sousa, Andrea Silvestre
Maciel, Erica Rodrigues
Carneiro, Fernanda Martins
Silva, Paula Simplicio da
Sangenis, Luiz Henrique Conde
Veloso, Henrique Horta
Cardoso, Claudia Santos de Aguiar
Bonecini-Almeida, Maria da Gloria
Souza, Andreia Lamoglia
Roma, Eric Henrique
Azevedo, Marcos José
Pereira-Silva, Fernanda Sant'Ana
Pimentel, Luis Otavio
Mendes, Marcelo Oliveira
Garzoni, Luciana Ribeiro
Gonzaga, Beatriz M. S.
Carvalho, Anna Cristina Calçada
Brasil, Pedro Emmanuel Alvarenga Americano
Silva, Gilberto Marcelo Sperandio da
Araújo-Jorge, Tania Cremonini
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Holanda, Marcelo Teixeira
Mediano, Mauro Felippe Felix
Hasslocher-Moreno, Alejandro Marcel
Xavier, Sérgio Salles
Saraiva, Roberto Magalhães
Sousa, Andrea Silvestre
Maciel, Erica Rodrigues
Carneiro, Fernanda Martins
Silva, Paula Simplicio da
Sangenis, Luiz Henrique Conde
Veloso, Henrique Horta
Cardoso, Claudia Santos de Aguiar
Bonecini-Almeida, Maria da Gloria
Souza, Andreia Lamoglia
Roma, Eric Henrique
Azevedo, Marcos José
Pereira-Silva, Fernanda Sant'Ana
Pimentel, Luis Otavio
Mendes, Marcelo Oliveira
Garzoni, Luciana Ribeiro
Gonzaga, Beatriz M. S.
Carvalho, Anna Cristina Calçada
Brasil, Pedro Emmanuel Alvarenga Americano
Silva, Gilberto Marcelo Sperandio da
Araújo-Jorge, Tania Cremonini
dc.subject.en.pt_BR.fl_str_mv Chagas cardiomyopathy
Chagas disease
Clinical trial
Selenium
Trypanosoma cruzi
topic Chagas cardiomyopathy
Chagas disease
Clinical trial
Selenium
Trypanosoma cruzi
description Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
publishDate 2018
dc.date.issued.fl_str_mv 2018
dc.date.accessioned.fl_str_mv 2019-07-12T13:15:15Z
dc.date.available.fl_str_mv 2019-07-12T13:15:15Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv HOLANDA, Marcelo Teixeira et al. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials, v. 19, p. 1-3, 2018.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/34020
dc.identifier.issn.pt_BR.fl_str_mv 1745-6215
dc.identifier.doi.none.fl_str_mv 10.1186/s13063-018-2889-8
dc.identifier.eissn.none.fl_str_mv 1745-6215
identifier_str_mv HOLANDA, Marcelo Teixeira et al. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials, v. 19, p. 1-3, 2018.
1745-6215
10.1186/s13063-018-2889-8
url https://www.arca.fiocruz.br/handle/icict/34020
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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