Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC). 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 a Steering Committee, and an independent Safety Monitoring Board.
A randomized double-blind controlled clinical trial investigating the role of benznidazole in patients with chronic Chagas' heart disease. Chagas disease has 3 phases: acute, undetermined and chronic phases. There are no clinical trials up to date that have investigated the use of antiparasitic drugs in patients that are in the chronic phase. This study will evaluate the efficacy and safety of benznidazole (an antiparasitic drug) in patients with chronic Chagas' heart disease. Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC). It will be developed in 49 study centres in Argentina, Bolivia,Brazil,Colombia, and El Salvador - countries with high incidence of Chagas Disease. The Pilot study is evaluating if benznidazole is effective in producing parasitic cure (PCR negativization or reducing parasitic load) in chronic Chagas Disease as well as assessing the feasibility of conducting a large trial in chronic Chagas Disease in South America.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2,854
Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg)
BENEFIT Ivestigational Site
Buenos Aires, Apital Federal, Argentina
BENEFIT Investigational Site
Belén de Escobar, Buenos Aires, Argentina
BENEFIT Investigational Site
Isidro Casanova, Buenos Aires, Argentina
BENEFIT Investigational Site
San Juan, Buenos Aires, Argentina
BENEFIT Investigational Site
Santiago Del Estero, Buenos Aires, Argentina
Composite of First of cardiovascular events: Death, Resuscitated Cardiac Arrest, Sustained VentricularTachycardia, New/worsening Heart Failure, New Pacemaker/ICD, Stroke/TIA or other Embolic Events, Cardiac Transplant.
Composite cardiovascular outcome,
Time frame: through study completion, an average of 5 years
New development of any of the following echo changes, segmental wall motion abnormalities, ventricular aneurysm, reduction in LV ejection fraction >5%, increase in LVDD> 5 mm compared to baseline.
Time frame: through study completion, an average of 5 years
New 12 lead ECG alterations (complete bundle branch block, fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc).
Time frame: through study completion, an average of 5 years
Progression of NYHA functional class by at least one category
Time frame: through study completion, an average of 5 years
New 12 lead electrocardiogram (ECG) alterations (complete bundle branch block; fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc.)
Time frame: through study completion, an average of 5 years
Progression of New York Heart Association (NYHA) functional class by at least one category
Time frame: through study completion, an average of 5 years
Evaluation of safety (adverse events: dermatitis, peripheral neuropathy, gastro-intestinal intolerance, leucopenia [2500 x 10^9 L]), tolerance and adherence to treatment
Time frame: through study completion, an average of 5 years
Determination of the efficacy of benznidazole in patients with Chronic Chagas heart disease based on a 50% reduction in both qualitative and quantitative PCR.
Polymerase Chain Reaction study on patient's blood samples and report negativization at the end of treatment, 2Y and final visit.
Time frame: through study completion, an average of 5 years
Safety and tolerability of benznidazole
Time frame: through study completion, an average of 5 years
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BENEFIT Investigational Site
Santiago Del Estero, Buenos Aires, Argentina
BENEFIT Investigational Site
Buenos Aires, Buenos Aires F.D., Argentina
BENEFIT Investigational Site
Catamarca, Catamarca Province, Argentina
BENEFIT Investigational Site
Charata, Chaco Province, Argentina
BENEFIT Investigational Site
Paraná, Entre Ríos Province, Argentina
...and 37 more locations