| Author | Marin Neto, José Antonio | |
| Author | Rassi Junior, Anis | |
| Author | Morillo, Carlos A. | |
| Author | Avezum Júnior, Álvaro | |
| Author | Connolly, Stuart J. | |
| Author | Sosa Estani, Sergio Alejandro | |
| Author | Rosas, Fernando | |
| Author | Yusuf, Salim | |
| Access date | 2024-07-09T13:06:13Z | |
| Available date | 2024-07-09T13:06:13Z | |
| Document date | 2008 | |
| 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. | |
| ISSN | 0002-8703 | |
| URI | https://www.arca.fiocruz.br/handle/icict/64901 | |
| Description | 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. | pt_BR |
| Description | Produção científica do Laboratório de Biologia Molecular e Doenças Endêmicas. | pt_BR |
| Sponsorship | BENEFIT is supported by Canadian Institutes of Health Research grant MCT-79704 and UNICEF/UDNP/World Bank/WHO, TDR grant A30755, Ministerio de Salud and Fundación Bunge y Born, Argentina, and seed funds from the PHRI. | |
| Language | eng | en_US |
| Publisher | Elsevier | |
| Rights | restricted access | |
| Title | 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) | en_US |
| Type | Article | |
| DOI | 10.1016/j.ahj.2008.04.001 | |
| 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. | en_US |
| Affilliation | Universidade de São Paulo. Faculdade de Medicina de Ribeirão Preto. Ribeirão Preto, SP, Brasil. | |
| Affilliation | Hospital do Coração Anis Rassi. Goiânia, GO, Brasil. | |
| Affilliation | McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada. | |
| Affilliation | Instituto Dante Pazzanese de Cardiologia. São Paulo, SP, Brasil. | |
| Affilliation | McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada. | |
| Affilliation | 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. | |
| Affilliation | Clinica A. Saio. Bogota, Colombia. | |
| Affilliation | McMaster University. Population Health Research Institute. HGH-McMaster Clinic. East Hamilton, Ontario, Canada. | |
| Subject | Placebo trial | en_US |
| Subject | Benznidazole | en_US |
| Subject | Trypanosoma cruzi | en_US |
| Subject | Chagas' disease | en_US |
| Subject | Cardiomyopathy | en_US |
| e-ISSN | 1097-6744 | |
