A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial.

Several studies evaluating clinical forms of chronic Chagas disease show that about one-third of patients present cardiac involvement. Heart failure, sudden death and cardioembolic stroke are the main mechanisms of death in Chagas heart disease. The impact of specific etiologic treatment on the prognosis of patients with chronic Chagas heart disease is very limited regardless of the presence or absence of heart failure. Patients with symptomatic Chagas heart disease present serum selenium (Se) levels lower than patients without Chagas heart disease. Moreover, Se supplementation in animal models showed promising results. The aim of this trial is to estimate the effect of Se treatment on prevention of heart disease progression in patients with Chagas cardiomyopathy. However, we had to introduce some protocol modifications in order to keep trial feasibility, as follows: the primary outcome was restricted to left ventricular ejection fraction as a continuous variable, excluding disease progression; the follow-up period was decreased from 5 years to 1 year, an adjustment that might increase the participation rate of our study; the superior age limit was increased from 65 to 75 years; and diabetes mellitus was no longer considered an exclusion criterion. All of these protocol modifications were extensively debated by the research team enrolled in the design, recruitment and conduction of the clinical trial to guarantee a high scientific quality. TRIAL REGISTRATION: Clinical Trials.gov, NCT00875173 . Registered on 20 October 2008.

Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study.

BACKGROUND: Several studies have been focusing on the effect of omega-3 polyunsaturated fatty acids on modulation of inflammatory markers in several cardiopathies. Although immunoregulatory dysfunction has been associated to the chronic cardiac involvement in Chagas disease, there is no study examining the effects of omega-3 supplementation in these patients. We investigated the effects of omega-3 PUFAs on markers of inflammation and lipid profile in chronic Chagas cardiomyopathy patients. METHODS: The present study was a single-center double-blind clinical trial including patients with chronic Chagas cardiomyopathy. Patients were randomly assigned to receive omega-3 PUFAs capsules (1.8g EPA and 1.2g DHA) or placebo (corn oil) during an 8-week period. Cytokines, fasting glucose, lipid, and anthropometric profiles were evaluated. RESULTS: Forty-two patients (23 women and 19 men) were included in the study and there were only two losses to follow-up during the 8-week period. Most of sociodemographic and clinical characteristics were similar between the groups at baseline, except for the cytokines IL-1ß, IL-6, IL-8, IL-10, IL-17α, and IFNγ. The omega-3 PUFAs group demonstrated greater improvements in serum triglycerides (-21.1 vs. -4.1; p = 0.05) and IL-10 levels (-10.6 vs. -35.7; p = 0.01) in comparison to controls after 8 weeks of intervention. No further differences were observed between groups. CONCLUSION: Omega-3 PUFAs supplementation may favorably affect lipid and inflammatory profile in chronic Chagas cardiomyopathy patients, demonstrated by a decrease in triglycerides and improvements on IL-10 concentration. Further studies examining the clinical effects of omega-3 fatty acids supplementation in chronic Chagas cardiomyopathy are necessary. TRIAL REGISTRATION: NCT01863576.

Atenção integral e eficiência no Laboratório de Pesquisa Clínica em Doenças de Chagas do Instituto de Pesquisa Clínica Evandro Chagas, 2009-2011 / Integrated health care and efficiency in the Chagas’ Disease Clinic Research Laboratory, Evandro Chagas Clinical Research Institute/Fiocruz, 2009-2011

Objetivo: caracterizar o grau de diversificação dos procedimentos requeridos do Modelo de Atenção Integral no tratamento da doença de Chagas e analisá-lo quanto à eficiência no uso de recursos em 2009-2011. Métodos: levantamento de microcustos e modelos de Custeio Baseado em Atividades e Análise Envoltória de Dados, no cálculo das despesas e custos unitários efetivos dos procedimentos para um estudo de caso de avaliação do desempenho do modelo de atenção do Laboratório de Pesquisa Clínica em Doença de Chagas/Instituto de Pesquisa Clínica Evandro Chagas/Fiocruz. Resultados: o grau de diversificação e a motivação pró-eficiência foram confirmados – 291 tipos de procedimentos em 2009, e ganho de eficiência de 19 por cento no período 2009-2011. Conclusão: a análise de eficiência revela poder explicativo sobre a tomada de decisão nas organizações públicas multipropósito de saúde, evidenciando a eficiência do modelo no tratamento da doença de Chagas e sua contribuição potencial para ações efetivas do Sistema Único de Saúde brasileiro (SUS).

Objective: to characterize the level of procedure diversification required by the Integral Health Care Model for Chagas disease treatment and assess it with respect to efficient use of resources. Methods: a microcosts survey, as well as Activity-Based Costing (ABC) and Data Envelopment Analysis (DEA) models, were used to calculate annual expenditure and actual unit costs of procedures for a case study assessing the performance of the Chagas’ Disease Clinic Research Laboratory/Evandro Chagas Clinical Research Institute/Fiocruz health care model. Results: diversification and pro-efficiency motivation were confirmed by the identification of 291 procedures types in 2009 and 19 per cent efficiency gain in the period 2009-2011. Conclusion: efficiency Analysis reveals explanatory power over decision-making in multipurpose public health organizations and demonstrated the efficiency of the model in Chagas disease treatment and its potential contribution to effective care actions in the Brazilian Unified Health System.

Sinal de Romaña e o diagnóstico de doença de Chagas / Romana's sign and the diagnosis of Chagas disease

Revisões históricas aos avanços científicos para o controle da doença, o Simpósio Internacional Comemorativo do Centenário da Descoberta da Doença de Chagas (1909-2009).