Clinical Trials Logo

Clinical Trial 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 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT00123916
Study type Interventional
Source Population Health Research Institute
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date August 2015

See also
  Status Clinical Trial Phase
Completed NCT03481322 - Low Sodium Cooking Study N/A
Completed NCT00001638 - Magnetic Resonance Imaging of the Blood Vessels of the Heart
Completed NCT02376244 - The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation N/A
Completed NCT02277379 - Prediction of Bleeding and Transfusion Outcomes and Assessment of Perioperative Platelet Reactivity in Cardiac Surgery N/A
Completed NCT02523144 - Dexmedetomidine in Children Having Transthoracic Echocardiography Phase 4
Completed NCT02045641 - Pleural and Pericardial Effusion Following Open Heart Surgery N/A
Completed NCT01871090 - Remote Device Interrogation In The Emergency Department N/A
Active, not recruiting NCT01400490 - Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study N/A
Completed NCT01192360 - Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease Phase 3
Terminated NCT00935766 - Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries Phase 3
Completed NCT00745446 - The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation N/A
Completed NCT00140816 - Dairy Products and Metabolic Effects (Norwegian Part) N/A
Completed NCT00178620 - Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization Phase 4
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Completed NCT01952171 - The Genetic Basis of Congenital Heart Disease in Africa
Recruiting NCT02933892 - Benefit of Transradial Approach in Chronic Kidney Disease Population Undergoing Cardiac Catheterization Phase 4
Withdrawn NCT02838355 - Employing End Tidal Capnography in Continuous Flow Ventricular Assist Device Patients N/A
Completed NCT02923518 - Cardiac Screening of Middle Aged and Older Women and Men (Master Athletes)
Terminated NCT02282163 - Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography Phase 3
Active, not recruiting NCT02260466 - Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement. N/A