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Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.
Trials. 2014 Oct 06; 15:388.T

Abstract

BACKGROUND

Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy.

METHODS

The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 μg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up.

DISCUSSION

If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost.

TRIAL REGISTRATION

Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).

Authors+Show Affiliations

Chagas Disease Clinical Research Laboratory, Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Avenida Brasil 4365, Manguinhos, Rio de Janeiro 21040-360, Brazil. pedro.brasil@ini.fiocruz.br.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25284194

Citation

Alvarenga Americano do Brasil, Pedro Emmanuel, et al. "Selenium Treatment and Chagasic Cardiopathy (STCC): Study Protocol for a Double-blind Randomized Controlled Trial." Trials, vol. 15, 2014, p. 388.
Alvarenga Americano do Brasil PE, Pereira de Souza A, Hasslocher-Moreno AM, et al. Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials. 2014;15:388.
Alvarenga Americano do Brasil, P. E., Pereira de Souza, A., Hasslocher-Moreno, A. M., Xavier, S. S., Lambert Passos, S. R., de Fátima Ramos Moreira, M., Santini de Oliveira, M., Sperandio da Silva, G. M., Magalhães Saraiva, R., Santos de Aguiar Cardoso, C., de Sousa, A. S., Mediano, M. F., Bonecini de Almeida, M. d. a. . G., da Cruz Moreira, O., Britto, C., & de Araújo-Jorge, T. C. (2014). Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. Trials, 15, 388. https://doi.org/10.1186/1745-6215-15-388
Alvarenga Americano do Brasil PE, et al. Selenium Treatment and Chagasic Cardiopathy (STCC): Study Protocol for a Double-blind Randomized Controlled Trial. Trials. 2014 Oct 6;15:388. PubMed PMID: 25284194.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial. AU - Alvarenga Americano do Brasil,Pedro Emmanuel, AU - Pereira de Souza,Andréa, AU - Hasslocher-Moreno,Alejandro Marcel, AU - Xavier,Sérgio Salles, AU - Lambert Passos,Sonia Regina, AU - de Fátima Ramos Moreira,Maria, AU - Santini de Oliveira,Marília, AU - Sperandio da Silva,Gilberto Marcelo, AU - Magalhães Saraiva,Roberto, AU - Santos de Aguiar Cardoso,Claudia, AU - de Sousa,Andréa Silvestre, AU - Mediano,Mauro Felippe Felix, AU - Bonecini de Almeida,Maria da Gloria, AU - da Cruz Moreira,Otacílio, AU - Britto,Constança, AU - de Araújo-Jorge,Tania Cremonini, Y1 - 2014/10/06/ PY - 2014/06/23/received PY - 2014/09/05/accepted PY - 2014/10/7/entrez PY - 2014/10/7/pubmed PY - 2015/5/29/medline SP - 388 EP - 388 JF - Trials JO - Trials VL - 15 N2 - BACKGROUND: Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy. METHODS: The Selenium Treatment and Chagasic Cardiopathy trial is a superiority, double-blind, placebo-controlled, randomized clinical trial. The eligibility criteria are as follows: (1) a Chagas disease diagnosis confirmed by serology; (2) segmental, mild or moderate global left ventricular systolic dysfunction; and (3) age between 18 and 65 years. The exclusion criteria are as follows: (1) pregnancy, (2) diabetes mellitus, (3) tobacco use, (4) alcohol abuse, (5) evidence of nonchagasic heart disease, (6) depression, (7) dysphagia with evidence of food residues in the esophagus, (8) dysphagia with weight loss higher than 15% of usual weight in the last four months and/or (9) conditions that may result in low protocol adherence. The intervention will be 100 μg of sodium selenite once daily for 365 consecutive days compared to placebo. The following are the primary outcomes to be measured: (1) the trajectories of the left ventricular ejection fraction in the follow-up period; (2) reduction of heart disease progression rates, with progression defined as a 10% decrease in left ventricular ejection fraction; and (3) rate of hospital admissions attributable to dysrhythmia, heart failure or stroke due to Chagas disease. One hundred thirty patients will be randomly allocated into either the intervention or placebo group at a ratio of 1:1. The sequence allocation concealment and blinding were planned to be conducted with the strategy of numbered boxes. Both patients and health-care providers will remain blinded to the intervention groups during the 5 years of follow-up. DISCUSSION: If Se treatment reduces the progression of Chagas cardiopathy, the inclusion of this micronutrient in the daily diet can improve the therapeutic regimen for this neglected tropical disease at low cost. TRIAL REGISTRATION: Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008). SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25284194/Selenium_Treatment_and_Chagasic_Cardiopathy__STCC_:_study_protocol_for_a_double_blind_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-388 DB - PRIME DP - Unbound Medicine ER -