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The purpose of this study is to determine if 60 days of treatment with an antiparasitic drug (benznidazole) could prevent the progression of cardiac disease in patients with Chagas disease.
The BENEFIT study is being conducted by the Population Health Research Institute (in Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil) together with an independent Steering Committee.
A randomized double-blind controlled clinical trial investigating the role of benznidazole in patients with chronic Chagas' heart disease.
Chagas disease has 3 phases: acute, undetermined and chronic phases. There are no clinical trials up to date that have investigated the use of antiparasitic drugs in patients that are in the chronic phase.
This study will evaluate the efficacy and safety of benznidazole (an antiparasitic drug) in patients with chronic Chagas' heart disease. It will evaluate if 60 days of drug treatment will reduce mortality and morbidity in patients with chronic Chagas' heart disease on several outcomes. It will be developed in 75 study centres in Argentina, Brazil, Colombia, Venezuela, Peru and Bolivia - countries with high incidence of Chagas Disease.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Published on BioPortfolio: 2014-08-27T03:52:48-0400
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Benznidazole is one of the two most effective antiparasitic drugs for Chagas' disease treatment. However, knowledge about its toxicity profile is mostly based on post-marketing observational studies.
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Benznidazole is the preferred drug for treatment of Chagas disease. However, it is toxic and of limited value in chronic infection.
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Chagas disease is caused by Trypanosoma cruzi. The persistence of the parasite is associated with the disease chronicity and the impairment of the cellular immune response. It has been reported that t...
A disease of the CARDIAC MUSCLE developed subsequent to the initial protozoan infection by TRYPANOSOMA CRUZI. After infection, less than 10% develop acute illness such as MYOCARDITIS (mostly in children). The disease then enters a latent phase without clinical symptoms until about 20 years later. Myocardial symptoms of advanced CHAGAS DISEASE include conduction defects (HEART BLOCK) and CARDIOMEGALY.
Infection with the protozoan parasite TRYPANOSOMA CRUZI, a form of TRYPANOSOMIASIS endemic in Central and South America. It is named after the Brazilian physician Carlos Chagas, who discovered the parasite. Infection by the parasite (positive serologic result only) is distinguished from the clinical manifestations that develop years later, such as destruction of PARASYMPATHETIC GANGLIA; CHAGAS CARDIOMYOPATHY; and dysfunction of the ESOPHAGUS or COLON.
A nitrovinyl furan used as a schistosomicidal agent and proposed for trypanosomiasis, especially Chagas disease.
The agent of South American trypanosomiasis or CHAGAS DISEASE. Its vertebrate hosts are man and various domestic and wild animals. Insects of several species are vectors.
A subfamily of assassin bugs (REDUVIIDAE) that are obligate blood-suckers of vertebrates. Included are the genera TRIATOMA; RHODNIUS; and PANSTRONGYLUS, which are vectors of TRYPANOSOMA CRUZI, the agent of CHAGAS DISEASE in humans.
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