A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
DOI: | 10.1186/s13063-018-2889-8 |
Texto Completo: | https://www.arca.fiocruz.br/handle/icict/34020 |
Resumo: | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. |
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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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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
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collection |
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bitstream.url.fl_str_mv |
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