Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial
Background: Chagas disease (caused by Trypanosoma cruzi infection) evolves to chronic chagasic cardiomyopathy (CCC) affecting 1.8 million people worldwide. This is the first randomized, placebo-controlled, double-blinded, clinical trial designed to estimate efficacy and safety of selenium (Se) treat...
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Elsevier
2021-10-01
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Series: | EClinicalMedicine |
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collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Marcelo T. Holanda Mauro F.F. Mediano Alejandro M. Hasslocher-Moreno Beatriz M.S. Gonzaga Anna Cristina C. Carvalho Roberto R. Ferreira Luciana R. Garzoni Fernanda S. Pereira-Silva Luis O. Pimentel Marcelo O. Mendes Marcos J. Azevedo Constança Britto Otacilio C. Moreira Alice G. Fernandes Carolina M. Santos Jéssica Constermani Vitor B. Paravidino Erica R. Maciel Fernanda M. Carneiro Sérgio S. Xavier Gilberto M. Sperandio da Silva Priscila F. Santos Henrique H. Veloso Pedro E.A.A. Brasil Andrea S. de Sousa Maria G. Bonecini-de-Almeida Paula S. da Silva Luiz Henrique C. Sangenis Roberto M. Saraiva Tania C. Araujo-Jorge |
spellingShingle |
Marcelo T. Holanda Mauro F.F. Mediano Alejandro M. Hasslocher-Moreno Beatriz M.S. Gonzaga Anna Cristina C. Carvalho Roberto R. Ferreira Luciana R. Garzoni Fernanda S. Pereira-Silva Luis O. Pimentel Marcelo O. Mendes Marcos J. Azevedo Constança Britto Otacilio C. Moreira Alice G. Fernandes Carolina M. Santos Jéssica Constermani Vitor B. Paravidino Erica R. Maciel Fernanda M. Carneiro Sérgio S. Xavier Gilberto M. Sperandio da Silva Priscila F. Santos Henrique H. Veloso Pedro E.A.A. Brasil Andrea S. de Sousa Maria G. Bonecini-de-Almeida Paula S. da Silva Luiz Henrique C. Sangenis Roberto M. Saraiva Tania C. Araujo-Jorge Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial EClinicalMedicine |
author_facet |
Marcelo T. Holanda Mauro F.F. Mediano Alejandro M. Hasslocher-Moreno Beatriz M.S. Gonzaga Anna Cristina C. Carvalho Roberto R. Ferreira Luciana R. Garzoni Fernanda S. Pereira-Silva Luis O. Pimentel Marcelo O. Mendes Marcos J. Azevedo Constança Britto Otacilio C. Moreira Alice G. Fernandes Carolina M. Santos Jéssica Constermani Vitor B. Paravidino Erica R. Maciel Fernanda M. Carneiro Sérgio S. Xavier Gilberto M. Sperandio da Silva Priscila F. Santos Henrique H. Veloso Pedro E.A.A. Brasil Andrea S. de Sousa Maria G. Bonecini-de-Almeida Paula S. da Silva Luiz Henrique C. Sangenis Roberto M. Saraiva Tania C. Araujo-Jorge |
author_sort |
Marcelo T. Holanda |
title |
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial |
title_short |
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial |
title_full |
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial |
title_fullStr |
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial |
title_full_unstemmed |
Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial |
title_sort |
effects of selenium treatment on cardiac function in chagas heart disease: results from the stcc randomized trial |
publisher |
Elsevier |
series |
EClinicalMedicine |
issn |
2589-5370 |
publishDate |
2021-10-01 |
description |
Background: Chagas disease (caused by Trypanosoma cruzi infection) evolves to chronic chagasic cardiomyopathy (CCC) affecting 1.8 million people worldwide. This is the first randomized, placebo-controlled, double-blinded, clinical trial designed to estimate efficacy and safety of selenium (Se) treatment in CCC. Methods: 66 patients with CCC stages B1 (left ventricular ejection fraction [LVEF] > 45% and no heart failure; n = 54) or B2 (LVEF < 45% and no heart failure; n = 12) were randomly assigned to receive 100 mcg/day sodium selenite (Se, n = 32) or placebo (Pla, n = 34) for one year (study period: May 2014-September 2018). LVEF changes over time and adverse effects were investigated. Trial registration number: NCT00875173 (clinicaltrials.gov). Findings: No significant differences between the two groups were observed for the primary outcome: mean LVEF after 6 (β= +1.1 p = 0.51 for Se vs Pla) and 12 months (β= +2.1; p = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (β= +10.1; p = 0.02 for Se [n = 4] vs Pla [n = 8]). Se treatment was safe for CCC patients, and the few adverse effects observed were similarly distributed across the two groups. Interpretation: Se treatment did not improve cardiac function (evaluated from LVEF) in CCC. However, in the subgroup of patients at B2 stage, a potential beneficial influence of Se was observed. Complementary studies are necessary to explore diverse Se dose and/or associations in different CCC stages (B2 and C), as well as in A and B1 stages with longer follow-up. Funding: Brazilian Ministry of Health, Fiocruz, CNPq, FAPERJ. |
url |
http://www.sciencedirect.com/science/article/pii/S2589537021003850 |
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doaj-813190663da340899121d57aac7d3a172021-08-30T04:13:59ZengElsevierEClinicalMedicine2589-53702021-10-0140101105Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized TrialMarcelo T. Holanda0Mauro F.F. Mediano1Alejandro M. Hasslocher-Moreno2Beatriz M.S. Gonzaga3Anna Cristina C. Carvalho4Roberto R. Ferreira5Luciana R. Garzoni6Fernanda S. Pereira-Silva7Luis O. Pimentel8Marcelo O. Mendes9Marcos J. Azevedo10Constança Britto11Otacilio C. Moreira12Alice G. Fernandes13Carolina M. Santos14Jéssica Constermani15Vitor B. Paravidino16Erica R. Maciel17Fernanda M. Carneiro18Sérgio S. Xavier19Gilberto M. Sperandio da Silva20Priscila F. Santos21Henrique H. Veloso22Pedro E.A.A. Brasil23Andrea S. de Sousa24Maria G. Bonecini-de-Almeida25Paula S. da Silva26Luiz Henrique C. Sangenis27Roberto M. Saraiva28Tania C. Araujo-Jorge29Laboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, BrazilLaboratory of Molecular Biology and Endemic Diseases, Oswaldo Cruz Institute (LABIMDOE-IOC/Fiocruz), Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Leonidas Deane, Rio de Janeiro 21040-360, BrazilLaboratory of Molecular Biology and Endemic Diseases, Oswaldo Cruz Institute (LABIMDOE-IOC/Fiocruz), Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Leonidas Deane, Rio de Janeiro 21040-360, BrazilLaboratory of Molecular Biology and Endemic Diseases, Oswaldo Cruz Institute (LABIMDOE-IOC/Fiocruz), Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Leonidas Deane, Rio de Janeiro 21040-360, BrazilLaboratory of Molecular Biology and Endemic Diseases, Oswaldo Cruz Institute (LABIMDOE-IOC/Fiocruz), Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Leonidas Deane, Rio de Janeiro 21040-360, BrazilLaboratory of Molecular Biology and Endemic Diseases, Oswaldo Cruz Institute (LABIMDOE-IOC/Fiocruz), Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Pavilhão Leonidas Deane, Rio de Janeiro 21040-360, BrazilDepartment of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, Rua São Francisco Xavier, 524, Pavilhão João Lyra Filho, 7° andar / blocos D e E, Maracanã, Rio de Janeiro 20550-013, Brazil; Department of Physical Education and Sports, Naval Academy, Avenida Almirante Silvio de Noronha, s/n, Castelo, Rio de Janeiro 20021-010, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Immunology and Immunogenetics, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilNutrition Service, Evandro Chagas Hospital, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Clinical Research in Chagas Disease, Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, BrazilLaboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute (LITEB-IOC/Fiocruz), Oswaldo Cruz Foundation (Fiocruz), Avenida Brasil 4365, Manguinhos, Pavilhão Cardoso Fontes, Sala 64, Rio de Janeiro 21040-360, Brazil; Corresponding author at: Laboratório de Inovações em Terapias, Ensino e Bioprodutos, Instituto Oswaldo Cruz, Fiocruz, Av. Brasil 4365, Pav. Cardoso Fontes, Manguinhos, Rio de Janeiro RJ 21040-900, Brasil.Background: Chagas disease (caused by Trypanosoma cruzi infection) evolves to chronic chagasic cardiomyopathy (CCC) affecting 1.8 million people worldwide. This is the first randomized, placebo-controlled, double-blinded, clinical trial designed to estimate efficacy and safety of selenium (Se) treatment in CCC. Methods: 66 patients with CCC stages B1 (left ventricular ejection fraction [LVEF] > 45% and no heart failure; n = 54) or B2 (LVEF < 45% and no heart failure; n = 12) were randomly assigned to receive 100 mcg/day sodium selenite (Se, n = 32) or placebo (Pla, n = 34) for one year (study period: May 2014-September 2018). LVEF changes over time and adverse effects were investigated. Trial registration number: NCT00875173 (clinicaltrials.gov). Findings: No significant differences between the two groups were observed for the primary outcome: mean LVEF after 6 (β= +1.1 p = 0.51 for Se vs Pla) and 12 months (β= +2.1; p = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (β= +10.1; p = 0.02 for Se [n = 4] vs Pla [n = 8]). Se treatment was safe for CCC patients, and the few adverse effects observed were similarly distributed across the two groups. Interpretation: Se treatment did not improve cardiac function (evaluated from LVEF) in CCC. However, in the subgroup of patients at B2 stage, a potential beneficial influence of Se was observed. Complementary studies are necessary to explore diverse Se dose and/or associations in different CCC stages (B2 and C), as well as in A and B1 stages with longer follow-up. Funding: Brazilian Ministry of Health, Fiocruz, CNPq, FAPERJ.http://www.sciencedirect.com/science/article/pii/S2589537021003850 |