Clinical Trial: Selenium Treatment and Chagasic Cardiopathy (STCC)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Selenium Treatment and Chagasic Cardiopathy (STCC): A Prospective Randomized Trial in Patients With Chagas Disease
Brief 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:
- low Se levels is related to the severity of the myocardiopathy in chagasic patients
- adequate Se diet is essential for mice survival at the acute phase of the experimental T. cruzi infection
- 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
Detailed Summary:
Several induced cardiomyopathy , Mycoplasma pneumonia-induced myocarditis, heart damage investigations have shown positive effects of Se on experimental models: cardiotoxicity induced by chemotherapics, ischemic cardiopathy, CVB3 and LP-BM5 (murine AIDS, retrovirus)-in reperfused heart, and in chagasic cardiopathy. In addition, beneficial effects of Se supplementation were reported in patients with myocardial infarct, Keshan disease, and cardiac dysfunction during HPN.
Our group has investigated the role and Se effect on infection by T. cruzi. By evaluating plasma Se levels in 170 chagasic patients, we discovered that the frequency of subjects with Se levels lower than normal was significantly higher in those with severe cardiopathy. Moreover, in this pioneering research, we found a positive correlation between Se levels and the LVEF, indicating that normal Se levels pave the way for efficient cardiac function. Later, we investigated if nutritional deficiency of this trace element interfered with the development of cardiopathy and the susceptibility to experimental T. cruzi infection. In that study, we found 100 % of mortality in Se deficient mice, while in the selenium adequate groups only 20% of the male and no female died even at 40 dpi. In addition, parasitemia levels of infected mice were not altered by Se deficiency, suggesting that the high susceptibility at the acute phase was not due to the parasite load. We later investigated if Se treatment could minimize the course of T. cruzi infection or the myocarditis in mice. We verified that the concentration of 4 ppm Se did not alter the resistance to infection but was able in preventing the increase of CK-MB levels in infected mice, indicating that Se helps to protect the heart from inflammatory damage driven by T. cruzi infection.
Currently, experimental and clinical t
Sponsor: Oswaldo Cruz Foundation
Current Primary Outcome: Ejection fraction by echocardiography [ Time Frame: Twice a year ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Electrocardiography [ Time Frame: twice a year ]
Original Secondary Outcome: Same as current
Information By: Oswaldo Cruz Foundation
Dates:
Date Received: October 20, 2008
Date Started: October 2008
Date Completion: December 2020
Last Updated: November 9, 2015
Last Verified: November 2015
