Carta Acesso aberto Produção Nacional Revisado por pares

A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial

2018; Springer Science+Business Media; Volume: 19; Issue: 1 Linguagem: Inglês

10.1186/s13063-018-2889-8

ISSN

1745-6215

Autores

Marcelo Teixeira de Holanda, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher‐Moreno, Sérgio Salles Xavier, Roberto Magalhães Saraiva, Andréa Silvestre de Sousa, Erica Rodrigues Maciel, Fernanda Martins Carneiro, Paula Simplício da Silva, Luiz Henrique Conde Sangenis, Henrique Horta Veloso, Cláudia Santos de Aguiar Cardoso, Maria da Glória Bonecini-Almeida, Andreia Lamoglia Souza, Eric Henrique Roma, Marcos José de Azevedo, Fernanda Sant’Ana Pereira-Silva, Luis O. Pimentel, Marcelo Oliveira Mendes, Luciana Ribeiro Garzoni, Beatriz Matheus de Souza Gonzaga, Anna Cristina Calçada Carvalho, Pedro Emmanuel Alvarenga Americano do Brasil, Gilberto Marcelo Sperandio da Silva, Tânia Cremonini de Araújo-Jorge,

Tópico(s)

Coenzyme Q10 studies and effects

Resumo

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

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