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A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial.
Trials. 2018 Sep 19; 19(1):507.T

Abstract

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.

TRIAL REGISTRATION

Clinical Trials.gov, NCT00875173 . Registered on 20 October 2008.

Authors+Show Affiliations

Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. marcelo.holanda@ini.fiocruz.br.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Evandro Chagas National Institute of Infectious Disease, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.Laboratory of Innovations in Therapies, Education and Bioproducts, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.

Pub Type(s)

Clinical Trial Protocol
Letter

Language

eng

PubMed ID

30231899

Citation

Holanda, Marcelo Teixeira, et al. "A Protocol Update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) Trial." Trials, vol. 19, no. 1, 2018, p. 507.
Holanda MT, Mediano MFF, Hasslocher-Moreno AM, et al. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials. 2018;19(1):507.
Holanda, M. T., Mediano, M. F. F., Hasslocher-Moreno, A. M., Xavier, S. S., Saraiva, R. M., Sousa, A. S., Maciel, E. R., Carneiro, F. M., da Silva, P. S., Sangenis, L. H. C., Veloso, H. H., Cardoso, C. S. A., Bonecini-Almeida, M. D. G., Souza, A. L., Roma, E. H., Azevedo, M. J., Pereira-Silva, F. S., Pimentel, L. O., Mendes, M. O., ... Araújo-Jorge, T. C. (2018). A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials, 19(1), 507. https://doi.org/10.1186/s13063-018-2889-8
Holanda MT, et al. A Protocol Update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) Trial. Trials. 2018 Sep 19;19(1):507. PubMed PMID: 30231899.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. AU - Holanda,Marcelo Teixeira, AU - Mediano,Mauro Felippe Felix, AU - Hasslocher-Moreno,Alejandro Marcel, AU - Xavier,Sérgio Salles, AU - Saraiva,Roberto Magalhães, AU - Sousa,Andrea Silvestre, AU - Maciel,Erica Rodrigues, AU - Carneiro,Fernanda Martins, AU - da Silva,Paula Simplicio, AU - Sangenis,Luiz Henrique Conde, AU - Veloso,Henrique Horta, AU - Cardoso,Claudia Santos de Aguiar, AU - Bonecini-Almeida,Maria da Gloria, AU - Souza,Andreia Lamoglia, AU - Roma,Eric Henrique, AU - Azevedo,Marcos José, AU - Pereira-Silva,Fernanda Sant'Ana, AU - Pimentel,Luis Otavio, AU - Mendes,Marcelo Oliveira, AU - Garzoni,Luciana Ribeiro, AU - Gonzaga,Beatriz M S, AU - Carvalho,Anna Cristina Calçada, AU - Brasil,Pedro Emmanuel Alvarenga Americano, AU - Sperandio da Silva,Gilberto Marcelo, AU - Araújo-Jorge,Tania Cremonini, Y1 - 2018/09/19/ PY - 2018/06/07/received PY - 2018/08/30/accepted PY - 2018/9/21/entrez PY - 2018/9/21/pubmed PY - 2019/1/8/medline KW - Chagas cardiomyopathy KW - Chagas disease KW - Clinical trial KW - Selenium KW - Trypanosoma cruzi SP - 507 EP - 507 JF - Trials JO - Trials VL - 19 IS - 1 N2 - : 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. TRIAL REGISTRATION: Clinical Trials.gov, NCT00875173 . Registered on 20 October 2008. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/30231899/A_protocol_update_for_the_Selenium_Treatment_and_Chagasic_Cardiomyopathy__STCC__trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2889-8 DB - PRIME DP - Unbound Medicine ER -