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Research

Photo for BENEFIT

BENEFIT

Official Title

BENznidazole Evaluation for Interrupting Trypanosomiasis Trial

Status

Ongoing

Overview

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.

Study Design

Randomized, double-blind, placebo control, safety/efficacy study, single group assignment, treatment.

Primary Endpoint

Adjudicated. Cardiac Arrest or other thromboembolic event in patients w/no prior thromboembolic phenomena or death Secondary Endpoint: New development of the following echo changes; segmental wall motion abnormalities, ventricular aneurysm, reduction in LV ejection fraction > 5%, increase in LVDD > 5.0 mm compared with baseline. New 12 lead ECG alterations (complete bundle branch block, fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc). Progression of NYHA functional class by at least one category.

Number of Patients

3000

Number of Sites

50

Number of Countries

5

Study Period

2004–2014

Principal Investigator

Carlos Morillo

Program Manager

Susan Chrolavicius, Brandi Meeks

Research Coordinator

Laura Bonilla

Key Publications

  • Marin-Neto, JA, Raasi Jr., A, Morillo, CA, Avezum, A, Connolly, SJ, Sosa-Estani, S, Rosas, F, Yusuf, S for the BENEFIT Investigators. Rational and design of a randomized placebo-controlled assessing the effects of etiologic treatment in Chagas’ cardiomyopathy: The BENznidazole Evaluation For Interrupting Trypanosmiasis (BENEFIT). AM Heart J; 2008; 156(1): 37-43.