Skip to main content
main-content

01.12.2018 | Update | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Marcelo Teixeira Holanda, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Sérgio Salles Xavier, Roberto Magalhães Saraiva, Andrea Silvestre Sousa, Erica Rodrigues Maciel, Fernanda Martins Carneiro, Paula Simplicio da Silva, Luiz Henrique Conde Sangenis, Henrique Horta Veloso, Claudia Santos de Aguiar Cardoso, Maria da Gloria Bonecini-Almeida, Andreia Lamoglia Souza, Eric Henrique Roma, Marcos José Azevedo, Fernanda Sant’Ana Pereira-Silva, Luis Otavio Pimentel, Marcelo Oliveira Mendes, Luciana Ribeiro Garzoni, Beatriz M. S. Gonzaga, Anna Cristina Calçada Carvalho, Pedro Emmanuel Alvarenga Americano Brasil, Gilberto Marcelo Sperandio da Silva, Tania Cremonini Araújo-Jorge

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.
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2018

Trials 1/2018 Zur Ausgabe