Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2014 |
| Outros Autores: | , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/10180 |
Resumo: | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil. |
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Brasil, Pedro Emmanuel Alvarenga Americano doSouza, Andréa Pereira deHasslocher-Moreno, Alejandro MarcelXavier, Sérgio SallesPassos, Sonia Regina LambertMoreira, Maria de Fátima RamosOliveira, Marília Santini deSilva, Gilberto Marcelo Sperandio daSaraiva, Roberto MagalhãesCardoso, Claudia Santos de AguiarSousa, Andréa Silvestre deMediano, Mauro Felippe FelixAlmeida, Maria da Glória Bonecini deMoreira, Otacílio da CruzBritto, ConstançaAraujo-Jorge, Tania C.2015-05-04T16:34:36Z2015-05-04T16:34:36Z2014BRASIL, Pedro Emmanuel Alvarenga Americano do et al. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials, v. 15, n. 338, p. 1-7, 2014.1745-6215https://www.arca.fiocruz.br/handle/icict/1018010.1186/1745-6215-15-388engBioMed CentralTrypanosoma cruziDoença de ChagasSelênioCardiomiopatia ChagásicaEnsaio ClínicoChagas cardiomyopathyChagas diseaseClinical TrialSeleniumTrypanosoma cruziTrypanosoma cruziSelenioCardiomiopatía ChagásicaEnsaio ClínicoSelênioCardiomiopatia ChagásicaSelenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de 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. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Epidemiologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sérgio Arouca. Centro de Estudos da Saúde do Trabalhador e Ecologia Humana (CESTEH). Laboratório de Toxicologia. Setor Metal. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e Aids. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Departamento de Nutrição. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Imunologia e Imunogenética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Biologia Molecular e Doenças Endêmicas. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Inovações em Terapias, Ensino e Bioprodutos. Rio de Janeiro, RJ, Brasil.Background: Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy. Methods: The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 μg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up. Discussion: If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1914https://www.arca.fiocruz.br/bitstream/icict/10180/1/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD51ORIGINALotacilio_moreira2etal_IOC_2014.pdfapplication/pdf302620https://www.arca.fiocruz.br/bitstream/icict/10180/2/otacilio_moreira2etal_IOC_2014.pdf89c81557b259b36af71829f1bd04938fMD52TEXTotacilio_moreira2etal_IOC_2014.pdf.txtotacilio_moreira2etal_IOC_2014.pdf.txtExtracted texttext/plain39575https://www.arca.fiocruz.br/bitstream/icict/10180/3/otacilio_moreira2etal_IOC_2014.pdf.txt0672a63fd6a8ce9362fc88c698903645MD53icict/101802023-09-14 15:37:30.71oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-09-14T18:37:30Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.pt_BR.fl_str_mv |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| title |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| spellingShingle |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial Brasil, Pedro Emmanuel Alvarenga Americano do Trypanosoma cruzi Doença de Chagas Selênio Cardiomiopatia Chagásica Ensaio Clínico Chagas cardiomyopathy Chagas disease Clinical Trial Selenium Trypanosoma cruzi Trypanosoma cruzi Selenio Cardiomiopatía Chagásica Ensaio Clínico Selênio Cardiomiopatia Chagásica |
| title_short |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| title_full |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| title_fullStr |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| title_full_unstemmed |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| title_sort |
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial |
| author |
Brasil, Pedro Emmanuel Alvarenga Americano do |
| author_facet |
Brasil, Pedro Emmanuel Alvarenga Americano do Souza, Andréa Pereira de Hasslocher-Moreno, Alejandro Marcel Xavier, Sérgio Salles Passos, Sonia Regina Lambert Moreira, Maria de Fátima Ramos Oliveira, Marília Santini de Silva, Gilberto Marcelo Sperandio da Saraiva, Roberto Magalhães Cardoso, Claudia Santos de Aguiar Sousa, Andréa Silvestre de Mediano, Mauro Felippe Felix Almeida, Maria da Glória Bonecini de Moreira, Otacílio da Cruz Britto, Constança Araujo-Jorge, Tania C. |
| author_role |
author |
| author2 |
Souza, Andréa Pereira de Hasslocher-Moreno, Alejandro Marcel Xavier, Sérgio Salles Passos, Sonia Regina Lambert Moreira, Maria de Fátima Ramos Oliveira, Marília Santini de Silva, Gilberto Marcelo Sperandio da Saraiva, Roberto Magalhães Cardoso, Claudia Santos de Aguiar Sousa, Andréa Silvestre de Mediano, Mauro Felippe Felix Almeida, Maria da Glória Bonecini de Moreira, Otacílio da Cruz Britto, Constança Araujo-Jorge, Tania C. |
| author2_role |
author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
Brasil, Pedro Emmanuel Alvarenga Americano do Souza, Andréa Pereira de Hasslocher-Moreno, Alejandro Marcel Xavier, Sérgio Salles Passos, Sonia Regina Lambert Moreira, Maria de Fátima Ramos Oliveira, Marília Santini de Silva, Gilberto Marcelo Sperandio da Saraiva, Roberto Magalhães Cardoso, Claudia Santos de Aguiar Sousa, Andréa Silvestre de Mediano, Mauro Felippe Felix Almeida, Maria da Glória Bonecini de Moreira, Otacílio da Cruz Britto, Constança Araujo-Jorge, Tania C. |
| dc.subject.other.pt_BR.fl_str_mv |
Trypanosoma cruzi Doença de Chagas Selênio Cardiomiopatia Chagásica Ensaio Clínico |
| topic |
Trypanosoma cruzi Doença de Chagas Selênio Cardiomiopatia Chagásica Ensaio Clínico Chagas cardiomyopathy Chagas disease Clinical Trial Selenium Trypanosoma cruzi Trypanosoma cruzi Selenio Cardiomiopatía Chagásica Ensaio Clínico Selênio Cardiomiopatia Chagásica |
| dc.subject.en.pt_BR.fl_str_mv |
Chagas cardiomyopathy Chagas disease Clinical Trial Selenium Trypanosoma cruzi |
| dc.subject.es.pt_BR.fl_str_mv |
Trypanosoma cruzi Selenio Cardiomiopatía Chagásica Ensaio Clínico |
| dc.subject.decs.pt_BR.fl_str_mv |
Selênio Cardiomiopatia Chagásica |
| description |
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em Doença de Chagas. Rio de Janeiro, RJ, Brasil. |
| publishDate |
2014 |
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2014 |
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2015-05-04T16:34:36Z |
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2015-05-04T16:34:36Z |
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info:eu-repo/semantics/article |
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BRASIL, Pedro Emmanuel Alvarenga Americano do et al. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials, v. 15, n. 338, p. 1-7, 2014. |
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https://www.arca.fiocruz.br/handle/icict/10180 |
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1745-6215 |
| dc.identifier.doi.pt_BR.fl_str_mv |
10.1186/1745-6215-15-388 |
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BRASIL, Pedro Emmanuel Alvarenga Americano do et al. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials, v. 15, n. 338, p. 1-7, 2014. 1745-6215 10.1186/1745-6215-15-388 |
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