Selenium Treatment and Chagasic Cardiopathy (STCC)

Summary

Background: Chagasic myocardiopathy caused by the protozoa Trypanosoma cruzi has been the principal cause of cardiac death in Latin America. Without any trypanocidal therapeutic intervention, infected subjects can pass from the indeterminate to the cardiac form with heart dysfunction. Our group has studied the role and the effect of the supplementation with the essential micronutrient selenium (Se) on T. cruzi infection, and the investigators have verified that: 1. low Se levels is related to the severity of the myocardiopathy in chagasic patients 2. adequate Se diet is essential for mice survival at the acute phase of the experimental T. cruzi infection 3. Se supplementation prevented the myocardial lesions at the acute phase in mice. From these findings and considering that Se supplementation was able to prevent Keshan cardiopathy, to revert electrocardiographic and echocardiographic alterations in patients nourished by parenteral route, and reduced re-infarction and cardiac deaths from acute myocardial infarction; the investigators purpose to investigate if Se treatment via oral route, is able to impair the progress of heart dysfunction in chagasic patients expressed by the study of progression rate and by the comparison of the means of ventricular ejection fraction. Methods: The Selenium treatment and Chagasic Cardiopathy (STCC) trial is double-blind, placebo controlled, randomized in 130 chagasic patients at the chronic phase following the inclusion criteria of (a) altered ECHO (LVEF between 0,35 % and 45 %), (b) age between 20 and 65 years, (c) randomly divided in two groups: Placebo (n=65) and Se (n=65). Patients of Se group will intake diary 100 µg Se as sodium selenite for 12 months. The primary endpoint is the reduction of 50 % in the progression rate of heart dysfunction, and the secondary endpoint is a partial or total reversion in electrocardiography alterations. Conclusion: This trial was recently approved by Brazilian Research Ethics Committee and will be conducted in accordance with the principles for human experimentation. If the investigators confirmed the benefit of Se treatment, a strategy of utilization a micronutrient in an adequate concentration as a treatment in diary diet can revolutionize the therapeutic for chagasic myocardiopathy.

Timeline

Start

2008-10

Primary completion

2016-12

Completion

2020-12

Publications

• Holanda MT, Mediano MFF, Hasslocher-Moreno AM, Gonzaga BMS, Carvalho ACC, Ferreira RR, Garzoni LR, Pereira-Silva FS, Pimentel LO, Mendes MO, Azevedo MJ, Britto C, Moreira OC, Fernandes AG, Santos CM, Constermani J, Paravidino VB, Maciel ER, Carneiro FM, Xavier SS, Sperandio da Silva GM, Santos PF, Veloso HH, Brasil PEAA, de Sousa AS, Bonecini-de-Almeida MG, da Silva PS, Sangenis LHC, Saraiva RM, Araujo-Jorge TC. Effects of Selenium treatment on cardiac function in Chagas heart disease: Results from the STCC randomized Trial. EClinicalMedicine. 2021 Aug 28;40:101105. doi: 10.1016/j.eclinm.2021.101105. eCollection 2021 Oct.
• Holanda MT, Mediano MFF, Hasslocher-Moreno AM, Xavier SS, Saraiva RM, Sousa AS, Maciel ER, Carneiro FM, da Silva PS, Sangenis LHC, Veloso HH, Cardoso CSA, Bonecini-Almeida MDG, Souza AL, Roma EH, Azevedo MJ, Pereira-Silva FS, Pimentel LO, Mendes MO, Garzoni LR, Gonzaga BMS, Carvalho ACC, Brasil PEAA, Sperandio da Silva GM, Araujo-Jorge TC. A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial. Trials. 2018 Sep 19;19(1):507. doi: 10.1186/s13063-018-2889-8.
• Alvarenga Americano do Brasil PE, Pereira de Souza A, Hasslocher-Moreno AM, Xavier SS, Lambert Passos SR, de Fatima Ramos Moreira M, Santini de Oliveira M, Sperandio da Silva GM, Magalhaes Saraiva R, Santos de Aguiar Cardoso C, de Sousa AS, Mediano MF, Bonecini de Almeida Mda G, da Cruz Moreira O, Britto C, de Araujo-Jorge TC. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials. 2014 Oct 6;15:388. doi: 10.1186/1745-6215-15-388.

Drugs

Indications