Effects of Selenium Treatment on Cardiac Function in Chagas Heart Disease: Results from the STCC Randomized Trial

Background: Chagas disease (caused by infection) evolves to chronic chagasic cardiomyopathy (CCC) affecting 1.8 million people worldwide. This is the first randomized, placebo-controlled, double-blinded, clinical trial designed to estimate efficacy and safety of selenium (Se) treatment in CCC.

Methods: 66 patients with CCC stages B1 (left ventricular ejection fraction [LVEF] > 45% and no heart failure; = 54) or B2 (LVEF < 45% and no heart failure; = 12) were randomly assigned to receive 100 mcg/day sodium selenite ( = 32) or placebo ( = 34) for one year (study period: May 2014-September 2018). LVEF changes over time and adverse effects were investigated. Trial registration number: NCT00875173 (clinicaltrials.gov).

Findings: No significant differences between the two groups were observed for the primary outcome: mean LVEF after 6 (β +1.1 = 0.51 for ) and 12 months (β +2.1; = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (β= +10.1; = 0.02 for [ = 4] [ = 8]). Se treatment was safe for CCC patients, and the few adverse effects observed were similarly distributed across the two groups.

Interpretation: Se treatment did not improve cardiac function (evaluated from LVEF) in CCC. However, in the subgroup of patients at B2 stage, a potential beneficial influence of Se was observed. Complementary studies are necessary to explore diverse Se dose and/or associations in different CCC stages (B2 and C), as well as in A and B1 stages with longer follow-up.

Funding: Brazilian Ministry of Health, Fiocruz, CNPq, FAPERJ.

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