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RATIONALE AND DESIGN OF A RANDOMIZED PLACEBO-CONTROLLED TRIAL ASSESSING THE EFFECTS OF ETIOLOGIC TREATMENT IN CHAGAS' CARDIOMYOPATHY: THE BENZNIDAZOLE EVALUATION FOR INTERRUPTING TRYPANOSOMIASIS (BENEFIT)
Produção científica do Laboratório de Biologia Molecular e Doenças Endêmicas.
Author
Affilliation
Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Ribeirão Preto, SP, Brasil.
Hospital do Coração Anis Rassi. Goiânia, GO, Brasil.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Instituto Dante Pazzanese de Cardiologia. São Paulo, SP, Brasil.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán". Centro Nacional Diagnóstico e Investigación de Endemo-Epidemias. Servicio de Epidemiología. Buenos Aires, Argentina.
Clinica A. Saio. Bogota, Colombia.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Hospital do Coração Anis Rassi. Goiânia, GO, Brasil.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Instituto Dante Pazzanese de Cardiologia. São Paulo, SP, Brasil.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán". Centro Nacional Diagnóstico e Investigación de Endemo-Epidemias. Servicio de Epidemiología. Buenos Aires, Argentina.
Clinica A. Saio. Bogota, Colombia.
McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada.
Abstract
Background: Benznidazole is effective for treating acute and chronic (recently acquired) Trypanosoma cruzi infection (Chagas' disease). Recent data indicate that parasite persistence plays a pivotal role in the pathogenesis of chronic Chagas' cardiomyopathy. However, the efficacy of trypanocidal therapy in preventing clinical complications in patients with preexisting cardiac disease is unknown. Study Design: BENEFIT is a multicenter, randomized, double-blind, placebo-controlled clinical trial of 3,000 patients with Chagas' cardiomyopathy in Latin America. Patients are randomized to receive benznidazole (5 mg/kg per day) or matched placebo, for 60 days. The primary outcome is the composite of death; resuscitated cardiac arrest; sustained ventricular tachycardia; insertion of pacemaker or cardiac defibrillator; cardiac transplantation; and development of new heart failure, stroke, or systemic or pulmonary thromboembolic events. The average follow-up time will be 5 years, and the trial has a 90% power to detect a 25% relative risk reduction. The BENEFIT program also comprises a substudy evaluating the effects of benznidazole on parasite clearance and an echo substudy exploring the impact of etiologic treatment on left ventricular function. Recruitment started in November 2004, and >1,000 patients have been enrolled in 35 centers from Argentina, Brazil, and Colombia to date. Conclusion: This is the largest trial yet conducted in Chagas' disease. BENEFIT will clarify the role of trypanocidal therapy in preventing cardiac disease progression and death.
Publisher
Elsevier
Citation
MARIN NETO, José Antonio et al. Rationale and design of a randomized placebo-controlled trial assessing the effects of etiologic treatment in Chagas' cardiomyopathy: the BENznidazole Evaluation For Interrupting Trypanosomiasis (BENEFIT). American Heart Journal, v. 156, n. 1, p. 37-43, July 2008.DOI
10.1016/j.ahj.2008.04.001ISSN
0002-8703Notes
Constança Felícia De Paoli de Carvalho Britto – Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.Produção científica do Laboratório de Biologia Molecular e Doenças Endêmicas.
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