Selenium Treatment and Chagasic Cardiopathy (STCC)
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Background:
Chagasic myocardiopathy caused by the protozoa Trypanosoma cruzi has been the principal cause
of cardiac death in Latin America. Without any trypanocidal therapeutic intervention,
infected subjects can pass from the indeterminate to the cardiac form with heart dysfunction.
Our group has studied the role and the effect of the supplementation with the essential
micronutrient selenium (Se) on T. cruzi infection, and the investigators have verified that:
1. low Se levels is related to the severity of the myocardiopathy in chagasic patients
2. adequate Se diet is essential for mice survival at the acute phase of the experimental
T. cruzi infection
3. Se supplementation prevented the myocardial lesions at the acute phase in mice. From
these findings and considering that Se supplementation was able to prevent Keshan
cardiopathy, to revert electrocardiographic and echocardiographic alterations in
patients nourished by parenteral route, and reduced re-infarction and cardiac deaths
from acute myocardial infarction; the investigators purpose to investigate if Se
treatment via oral route, is able to impair the progress of heart dysfunction in
chagasic patients expressed by the study of progression rate and by the comparison of
the means of ventricular ejection fraction.
Methods:
The Selenium treatment and Chagasic Cardiopathy (STCC) trial is double-blind, placebo
controlled, randomized in 130 chagasic patients at the chronic phase following the inclusion
criteria of (a) altered ECHO (LVEF between 0,35 % and 45 %), (b) age between 20 and 65 years,
(c) randomly divided in two groups: Placebo (n=65) and Se (n=65). Patients of Se group will
intake diary 100 µg Se as sodium selenite for 12 months. The primary endpoint is the
reduction of 50 % in the progression rate of heart dysfunction, and the secondary endpoint is
a partial or total reversion in electrocardiography alterations.
Conclusion:
This trial was recently approved by Brazilian Research Ethics Committee and will be conducted
in accordance with the principles for human experimentation. If the investigators confirmed
the benefit of Se treatment, a strategy of utilization a micronutrient in an adequate
concentration as a treatment in diary diet can revolutionize the therapeutic for chagasic
myocardiopathy.
Phase:
Phase 3
Details
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Ministry of Health, Brazil