Chagas Disease | BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
Chagas Disease research study
What is the primary objective of this study?
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 an independent Steering Committee.
Who is eligible to participate?
Inclusion Criteria: - Consenting patients (between 18 and 75 years of age) with serological evidence of Chagas infection (any combination of 2 positive tests) and that have one or more of the following: - Abnormal electrocardiogram with at least two components (complete RBBB or LBBB; left anterior or posterior fascicular block; ventricular premature beat; first degree atrioventricular [AV] block; Mobitz type I AV block; sinus bradycardia; primary ST-T changes; abnormal Q waves; low voltage QRS; or atrial fibrillation); - Abnormal ECG (Mobitz type II, advanced or third degree AV block); - Increased cardiothoracic ratio (> 0.50); - Complex ventricular arrythmias on 24 hour ambulatory ECG monitoring; - Evidence of regional wall motion abnormality or reduced global left ventricular systolic function or increased left ventricular and diastolic diameter on 2D-Echo. Exclusion Criteria: Patients will be excluded if having: - NYHA heart failure class IV or decompensated heart failure - Evidence of concomitant coronary artery disease (CAD) or other etiology of dilated cardiomyopathy - Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy - Inability to comply with follow-up visits - History of severe alcohol abuse within 2 years - Known chronic renal or hepatic insufficiency or hepatic insufficiency - Pregnancy or breast feeding - Megaesophagus with swallowing impairment - Other severe disease significantly curtailing life expectancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:BenznidazoleDaily po Benznidazole or placebo (weight based) during 60 days,
Drug:Placeboa 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)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Benznidazole60 days treatment with benznidazol
Placebo60 days treatment with matching placebo
Start Date: November 2004
Completed Date: July 2013
Phase: Phase 3
Primary Outcome: It will also evaluate the cardiovascular events of the large outcome trial, the first occurrence of any of the following clinically significant outcomes: Death
Secondary Outcome: New development of any of the following echo changes clinically indicated or done for the trial: Segmental wall motion abnormalities
Study sponsors, principal investigator, and references
Principal Investigator: Carlos Morillo, MD, FRCPC, FAC
Lead Sponsor: Population Health Research Institute
Collaborator: Canadian Institutes of Health Research (CIHR)