| dc.description | Background: Chronic chagasic cardiomyopathy is an inflammatory disease that occurs in approximately 30% of
patients infected by the protozoan Trypanosoma cruzi, and it has a profile of high morbidity and mortality. The worst
prognosis and the progression of this cardiomyopathy are associated with an exacerbated immune response and the
production of proinflammatory cytokines, which also occur in other cardiomyopathies. Some nutrients, including
omega-3 polyunsaturated fatty acids (PUFAs), promote the inhibition and/or stimulation of cytokine production. The
objective of this trial is to study the effects of omega-3 PUFA supplementation on the inflammatory response and lipid
profile in patients with chronic chagasic cardiomyopathy.
Methods/Design: This is a parallel, randomized, placebo-controlled, double-blind clinical trial with 40 patients that will
be conducted at a reference unit for Chagas disease patients, where the patients will be selected. The study will include
patients with chronic chagasic cardiomyopathy who are 18 years of age or older. The exclusion criteria are (a) ongoing
diarrheal disease, (b) inflammatory bowel disease, (c) diabetes or other endocrine disease, (d) use of fibrates, niacin, or
statins, (e) use of anti-inflammatory drugs, (f) pregnant and lactating women, (g) use of vitamin, mineral, or omega-3
supplementation during the previous 30 days, (h) hospital admission during the study, and (i) other associated
cardiomyopathies. The intervention will be treatment with omega-3 PUFAs at a dose of 3 g/day for 8 weeks,
compared to placebo (corn oil). The primary endpoints will be the concentrations of inflammatory markers
(interleukin (IL)-1, IL-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)α, interferon (IFN)γ, and transforming growth
factor (TGF)β). Secondary endpoints will be the fasting glucose, lipid, and anthropometric profiles. For statistical
analysis, we plan to run either a t test or Wilcoxon test (numerical variables) and Pearson’s χ2 or Fisher’s exact
test (categorical data), as appropriate.
Discussion: Evidence suggests that the anti-inflammatory action of omega-3 PUFAs may have beneficial effects on
chronic chagasic cardiomyopathy, as shown for other cardiomyopathies, due to improved control of the inflammatory
response. At the end of the study, we predict that patients will have lower inflammatory markers and an improved
metabolic and anthropometric profile. | |
