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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).
Am Heart J. 2008 Jul; 156(1):37-43.AH

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.

Authors+Show Affiliations

Medical School of Ribeirao Preto, University of Sao Paulo, Ribeirão Preto, Sao Paulo, Brazil. marin_neto@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18585495

Citation

Marin-Neto, Jose 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, vol. 156, no. 1, 2008, pp. 37-43.
Marin-Neto JA, Rassi A, Morillo CA, 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). Am Heart J. 2008;156(1):37-43.
Marin-Neto, J. A., Rassi, A., Morillo, C. A., Avezum, A., Connolly, S. J., Sosa-Estani, S., Rosas, F., & Yusuf, S. (2008). 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, 156(1), 37-43. https://doi.org/10.1016/j.ahj.2008.04.001
Marin-Neto JA, 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). Am Heart J. 2008;156(1):37-43. PubMed PMID: 18585495.
* Article titles in AMA citation format should be in sentence-case
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 -