TY - JOUR T1 - 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). AU - Marin-Neto,Jose Antonio, AU - Rassi,Anis,Jr AU - Morillo,Carlos A, AU - Avezum,Alvaro, AU - Connolly,Stuart J, AU - Sosa-Estani,Sergio, AU - Rosas,Fernando, AU - Yusuf,Salim, AU - ,, PY - 2007/09/21/received PY - 2008/04/01/accepted PY - 2008/7/1/pubmed PY - 2008/8/1/medline PY - 2008/7/1/entrez SP - 37 EP - 43 JF - American heart journal JO - Am Heart J VL - 156 IS - 1 N2 - 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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/18585495/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__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(08)00234-2 DB - PRIME DP - Unbound Medicine ER -