| Autor: |
Marcelo T. Holanda, Mauro F.F. Mediano, Alejandro M. Hasslocher-Moreno, Beatriz M.S. Gonzaga, Anna Cristina C. Carvalho, Roberto R. Ferreira, Luciana R. Garzoni, Fernanda S. Pereira-Silva, Luis O. Pimentel, Marcelo O. Mendes, Marcos J. Azevedo, Constança Britto, Otacilio C. Moreira, Alice G. Fernandes, Carolina M. Santos, Jéssica Constermani, Vitor B. Paravidino, Erica R. Maciel, Fernanda M. Carneiro, Sérgio S. Xavier, Gilberto M. Sperandio da Silva, Priscila F. Santos, Henrique H. Veloso, Pedro E.A.A. Brasil, Andrea S. de Sousa, Maria G. Bonecini-de-Almeida, Paula S. da Silva, Luiz Henrique C. Sangenis, Roberto M. Saraiva, Tania C. Araujo-Jorge |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
|
| Zdroj: |
EClinicalMedicine, Vol 40, Iss , Pp 101105- (2021) |
| Druh dokumentu: |
article |
| ISSN: |
2589-5370 |
| DOI: |
10.1016/j.eclinm.2021.101105 |
| Popis: |
Background: Chagas disease (caused by Trypanosoma cruzi 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; n = 54) or B2 (LVEF < 45% and no heart failure; n = 12) were randomly assigned to receive 100 mcg/day sodium selenite (Se, n = 32) or placebo (Pla, n = 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 p = 0.51 for Se vs Pla) and 12 months (β= +2.1; p = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (β= +10.1; p = 0.02 for Se [n = 4] vs Pla [n = 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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
|
