title: Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinical Trials.gov ID: NCT00875173 (registered 20 October 20 2008).
authors.affiliation: 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.
authors.forename: Pedro Emmanuel
authors.initials: PE
authors.lastname: Alvarenga Americano do Brasil
authors.forename: Andréa
authors.initials: A
authors.lastname: Pereira de Souza
authors.forename: Alejandro Marcel
authors.initials: AM
authors.lastname: Hasslocher-Moreno
authors.forename: Sérgio Salles
authors.initials: SS
authors.lastname: Xavier
authors.forename: Sonia Regina
authors.initials: SR
authors.lastname: Lambert Passos
authors.forename: Maria
authors.initials: M
authors.lastname: de Fátima Ramos Moreira
authors.forename: Marília
authors.initials: M
authors.lastname: Santini de Oliveira
authors.forename: Gilberto Marcelo
authors.initials: GM
authors.lastname: Sperandio da Silva
authors.forename: Roberto
authors.initials: R
authors.lastname: Magalhães Saraiva
authors.forename: Claudia
authors.initials: C
authors.lastname: Santos de Aguiar Cardoso
authors.forename: Andréa Silvestre
authors.initials: AS
authors.lastname: de Sousa
authors.forename: Mauro Felippe Felix
authors.initials: MF
authors.lastname: Mediano
authors.forename: Maria da Gloria
authors.initials: Mda G
authors.lastname: Bonecini de Almeida
authors.forename: Otacílio
authors.initials: O
authors.lastname: da Cruz Moreira
authors.forename: Constança
authors.initials: C
authors.lastname: Britto
authors.forename: Tania Cremonini
authors.initials: TC
authors.lastname: de Araújo-Jorge
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001938:Brazil; D002598:Chagas Cardiomyopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D002985:Clinical Protocols; D019587:Dietary Supplements / Q000009:adverse effects; D018450:Disease Progression; D004311:Double-Blind Method; D005247:Feeding Behavior; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D009752:Nutritional Status; D011788:Quality of Life; D012107:Research Design; D018038:Sodium Selenite / Q000009:adverse effects / Q000627:therapeutic use*; D013318:Stroke Volume / Q000187:drug effects; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects; D055815:Young Adult
chemical_list: D018038:Sodium Selenite