Status:
COMPLETED
BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
World Health Organization
Conditions:
Chagas Disease
Trypanosomiasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 adjuste...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
2854 Patients enrolled
Trial Details
Trial ID
NCT00123916
Start Date
November 1 2004
End Date
August 1 2015
Last Update
March 3 2020
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
BENEFIT Ivestigational Site
Buenos Aires, Apital Federal, Argentina, 3556
2
BENEFIT Investigational Site
Belén de Escobar, Buenos Aires, Argentina, 1753
3
BENEFIT Investigational Site
Isidro Casanova, Buenos Aires, Argentina, 1282
4
BENEFIT Investigational Site
San Juan, Buenos Aires, Argentina, 1625