A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial (original) (raw)
Related papers
EClinicalMedicine, 2021
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, doubleblinded, 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 (b= +1.1 p = 0.51 for Se vs Pla) and 12 months (b= +2.1; p = 0.23). In a subgroup analysis, statistically significant longitudinal changes were observed for mean LVEF in the stage B2 subgroup (b= +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.
Trials, 2014
Heart disease progression occurs in 30% of patients with chronic Trypanosoma cruzi infection. Supplementation with selenium (Se) in animal model of T. cruzi infection produced promising results. There is evidence that patients with Chagas heart disease have lower Se levels than healthy individuals and patients with T. cruzi infection without of cardiac disease. The aim of this investigation is to estimate the effect of Se treatment on prevention of heart disease progression in patients with chagasic cardiopathy.
Biomolecules, 2022
For over 60 years, selenium (Se) has been known as an essential microelement to many biological functions, including cardiovascular homeostasis. This review presents a compilation of studies conducted in the past 20 years related to chronic Chagas disease cardiomyopathy (CCC), caused by Trypanosoma cruzi infection, a neglected disease that represents a global burden, especially in Latin America. Experimental and clinical data indicate that Se may be used as a complementary therapy to prevent heart failure and improve heart function. Starting from the main questions “Is Se deficiency related to heart inflammation and arrhythmogenesis in CCC?” and “Could Se be recommended as a therapeutic strategy for CCC?”, we show evidence implicating the complex and multidetermined CCC physiopathology, discussing its possible interplays with the multifunctional cytokine TGF-β as regulators of immune response and fibrosis. We present two new proposals to face this global public health challenge in v...
Would selenium supplementation aid in therapy for Chagas Disease?
Trends in Parasitology, 2011
Chagas disease, a neglected tropical disease discovered over 100 years ago, is caused by the intracellular parasite Trypanosoma cruzi and is most frequently associated with chronic cardiomyopathy and digestive disorders. Initial invasion of cells is followed by progressive inflammatory destruction of heart, muscles, nerves, and gastrointestinal (GI) tract tissue. About 30% of patients progress to a chronic cardiomyopathy associated with increased morbidity and mortality. Seven to 10% of patients develop megasyndromes involving the GI tract, in particular, the esophagus and the colon. Results from several studies suggest that selenium (Se) deficiency may be an important factor in the pathogenesis of Chagas disease. In this opinion article, Se supplementation is proposed as an adjuvant therapy for treatment of chronic Chagas disease.
Memórias do Instituto Oswaldo Cruz, 2010
Cardiac damage is a frequent manifestation of Chagas disease, which is caused by the parasite Trypanosoma cruzi. Selenium (Se) is an essential micronutrient, the deficiency of which has been implicated in the development of cardiomyopathy. Our group has previously demonstrated that Se supplementation prevents myocardial damage during acute T. cruzi infection in mice. In this study, we analyzed the effect of Se treatment in cases of T. cruzi infection using prevention and reversion schemes. In the Se prevention scheme, mice were given Se supplements (2 ppm) starting two weeks prior to inoculation with T. cruzi (Brazil strain) and continuing until 120 days post-infection (dpi). In the Se reversion scheme, mice were treated with Se (4 ppm) for 100 days, starting at 160 dpi. Dilatation of the right ventricle was observed in the infected control group at both phases of T. cruzi infection, but it was not observed in the infected group that received Se treatment. Surviving infected mice that were submitted to the Se reversion scheme presented normal P wave values and reduced inflammation of the pericardium. These data indicate that Se treatment prevents right ventricular chamber increase and thus can be proposed as an adjuvant therapy for cardiac alterations already established by T. cruzi infection.
Congestive cardiomyopathy and the selenium content of serum
Clinica Chimica Acta, 1983
A deficiency of selenium is suspected to be involved in the pathogenesis of congestive cardiomyopathy. Therefore the serum selenium content of 20 patients with proven congestive cardiomyopathy was measured and compared to that of a healthy control group. The serum selenium content of the patients with cardiomyopathy was found to be different from that of the healthy control group. The mean value of selenium in serum for the control group was 80.1 pg Se/l (SD + 13.2) within a range of 53 and 117 pg Se/l. From the 20 patients with congestive cardiomyopathy six patients showed selenium concentrations in the normal value range of the control group; in the serum of 14 patients a distinct lower selenium content was found (mean value 47.8 pg Se/l (SD + 16.2)) within a range of 23 and 70 pg Se/l. A positive correlation was found between serum selenium content and the left ventricular ejection fraction. Our results suggest that a deficiency of selenium may be present in a number of patients with congestive cardiomyopathy.
Selenium and outcome in heart failure
European Journal of Heart Failure, 2019
AimsSevere deficiency of the essential trace element selenium can cause myocardial dysfunction although the mechanism at cellular level is uncertain. Whether, in clinical practice, moderate selenium deficiency is associated with worse symptoms and outcome in patients with heart failure is unknown.Methods and resultsBIOSTAT‐CHF is a multinational, prospective, observational cohort study that enrolled patients with worsening heart failure. Serum concentrations of selenium were measured by inductively coupled plasma mass spectrometry. Primary endpoint was a composite of all‐cause mortality and hospitalization for heart failure; secondary endpoint was all‐cause mortality. To investigate potential mechanisms by which selenium deficiency might affect prognosis, human cardiomyocytes were cultured in absence of selenium, and mitochondrial function and oxidative stress were assessed. Serum selenium concentration (deficiency) was <70 μg/L in 485 (20.4%) patients, who were older, more often...
The journal of Tehran Heart Center, 2012
Selenium (Se) is an essential trace element mainly obtained from seafood, meat, and cereals. Se deficiency has been identified as a major contributing factor in the pathogenesis of certain congestive heart failure (CHF) syndromes. Since there is controversy over the prevalence of Se deficiency among patient with CHF, the aim of this study was to assess the serum Se concentrations in patients with CHF and compared them with the Se status of healthy controls. The study included 77 patients (age, 68.4 ± 10.4 years old; 40.3% female) and 73 healthy volunteers (64.9 ± 4.7 years old; 35.6% female). A complete medical/drug history and physical examination were performed for all patients and healthy volunteers. All patients had symptoms and signs of CHF and had a left ventricular ejection fraction (EF) of < 40% obtained by echocardiography. The Se concentration was assessed by atomic absorption spectrometer with the Graphite Tube Atomizer. The limit of measurement was 5 μg/L. The Se conc...
The role of selenium deficiency in dilated cardiomyopathy in Saudi Arabia
Annals of Saudi medicine
Background: Selenium deficiency is implicated in the etiology of endemic juvenile dilated cardiomyopathy in China, and in sporadic cases in other countries. The aim of this study was to evaluate the role of selenium deficiency in the pathophysiology of dilated cardiomyopathy in the Saudi Arabian population. Patients and Methods: Plasma and urine selenium concentrations from 72 Saudi patients with confirmed dilated cardiomyopathy were compared with corresponding values from 70 control subjects of the same national origin who had normal ventricular function. Results: Plasma and urine selenium concentrations (mean±SD) were 1.34±0.45 and 0.49±0.37 µmol/L, respectively, for the patient group, and 1.32±0.41 and 0.60±0.41 µmol/L, respectively, for the control group. The differences in the values between the two groups were statistically insignificant. Conclusion: In the Saudi population, dilated cardiomyopathy is not caused by selenium deficiency.