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Selenium Treatment and Chagasic Cardiopathy ( STCC ) : study protocol for a double-blind randomized controlled trial . 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 ) .
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Intervention_Physical
Selenium Treatment
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Intervention_Physical
Chagasic Cardiopathy ( STCC )
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Intervention_Physical
Se treatment
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Outcome_Physical
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
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Outcome_Physical
progression of Chagas cardiopathy
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Participant_Condition
patients with Chagas heart disease
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Participant_Condition
patients with chagasic cardiopathy
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Participant_Condition
a Chagas disease diagnosis confirmed by serology
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Participant_Condition
mild or moderate global left ventricular systolic dysfunction ;
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Participant_Age
age between 18 and 65 years
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Participant_Condition
diabetes mellitus ,
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Participant_Condition
tobacco use ,
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Participant_Condition
alcohol abuse
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Participant_Condition
evidence of nonchagasic heart disease
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Participant_Condition
depression
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Participant_Condition
dysphagia