BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
NCT ID: NCT00123916
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2854 participants
INTERVENTIONAL
2004-11-30
2015-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benznidazole
40 - 80 days (according to body weight) treatment with benznidazol
Benznidazole
Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
Placebo
40 - 80 days (according to body weight) treatment with matching placebo
Placebo
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)
Interventions
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Benznidazole
Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
Placebo
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
World Health Organization
OTHER
Instituto Dante Pazzanese de Cardiologia
OTHER
University of Sao Paulo
OTHER
Population Health Research Institute
OTHER
Responsible Party
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Salim Yusuf's office
Principal Co-Investigator
Principal Investigators
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Carlos Morillo, MD
Role: STUDY_CHAIR
Population Health Research Institute - McMaster University
Jose Antonio Marin-Neto, MD, PhD
Role: STUDY_CHAIR
University of Sao Paulo
Salim Yusuf, MD, DPh
Role: STUDY_CHAIR
Population Health Research Institute - McMaster University
Sergio Sosa-Estani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Argentina National Coordinator - CenDIE, Argentina
Fernando Rosas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fundacion Clinica Shaio, Bogota, Colombia
Locations
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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
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
BENEFIT Investigational Site
Buenos Aires, General Rodríguez Partido, Argentina
BENEFIT Investigational Site
San Salvador de Jujuy, Jujuy Province, Argentina
BENEFIT Investigational Site
Corrientes, Rosario, Santa Fe, Argentina
BENEFIT Investigational Site
Rosario, Santa Fe Province, Argentina
BENEFIT Investigational Site
Añatuya, Santiago del Estero Province, Argentina
BENEFIT Investigational Site
Santiago del Estero, Sgo. Del Estero, Argentina
BENEFIT Investigational Site
Buenos Aires, , Argentina
BENEFIT Investigational Site
Salta, , Argentina
BENEFIT Investigational Site
Tupiza, Potosí Department, Bolivia
BENEFIT Investigational Site
Salvador, Bahaia, Brazil
BENEFIT Investigational Site
Salvador, Bahaia, Brazil
BENEFIT Investigational Site
Salvador, Bahaia, Brazil
BENEFIT Investigational Site
Carmo, Belo Horizonte, Brazil
BENEFIT Investigational Site
Brasília, Brazilian Federal District, Brazil
BENEFIT Investigational Site
Goiânia, Goiás, Brazil
BENEFIT Investigational Site
Goiânia, Goiás, Brazil
BENEFIT Investigational Site
Goiânia, Goiás, Brazil
BENEFIT Investigational Site
Uberaba, Minas Gerais, Brazil
BENEFIT Investigational Site
Uberlândia, Minas Gerais, Brazil
BENEFIT Investigational Site
Uberlândia, Minas Gerais, Brazil
BENEFIT Investigational Site
Curitiba, Paraná, Brazil
BENEFIT Investigational Site
Recife, Pernambuco, Brazil
BENEFIT Investigational Site
Pelotas, Rio Grande do Sul, Brazil
BENEFIT Investigational Site
Campinas, São Paulo, Brazil
BENEFIT Investigational Site
Ribeirão Preto, São Paulo, Brazil
BENEFIT Investigational Site
São José do Rio Preto, São Paulo, Brazil
BENEFIT Investigational Site
São José do Rio Preto, São Paulo, Brazil
BENEFIT Investigational Site
Votuporanga, São Paulo, Brazil
BENEFIT Investigational Site
Rio de Janeiro, , Brazil
BENEFIT Investigational Site
Rio de Janeiro, , Brazil
BENEFIT Investigational Site
São Paulo, , Brazil
BENEFIT Investigational Site
São Paulo, , Brazil
BENEFIT Investigational Site
São Paulo, , Brazil
BENEFIT Investigational Site
São Paulo, , Brazil
BENEFIT Investigational Site
Bogotá, Bogota D.C., Colombia
BENEFIT Investigational Site
San Gil, Santander Department, Colombia
BENEFIT Ivestigational Site
San Salvador, , El Salvador
Countries
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References
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Marin-Neto JA, Rassi A Jr, Morillo CA, Avezum A, Connolly SJ, Sosa-Estani S, Rosas F, Yusuf S; BENEFIT Investigators. Rationale and design of a randomized placebo-controlled trial assessing the effects of etiologic treatment in Chagas' cardiomyopathy: the BENznidazole Evaluation For Interrupting Trypanosomiasis (BENEFIT). Am Heart J. 2008 Jul;156(1):37-43. doi: 10.1016/j.ahj.2008.04.001.
Morillo CA, Marin-Neto JA, Avezum A, Sosa-Estani S, Rassi A Jr, Rosas F, Villena E, Quiroz R, Bonilla R, Britto C, Guhl F, Velazquez E, Bonilla L, Meeks B, Rao-Melacini P, Pogue J, Mattos A, Lazdins J, Rassi A, Connolly SJ, Yusuf S; BENEFIT Investigators. Randomized Trial of Benznidazole for Chronic Chagas' Cardiomyopathy. N Engl J Med. 2015 Oct;373(14):1295-306. doi: 10.1056/NEJMoa1507574. Epub 2015 Sep 1.
Marin-Neto JA, Rassi A Jr, Avezum A Jr, Mattos AC, Rassi A, Morillo CA, Sosa-Estani S, Yusuf S; BENEFIT Investigators. The BENEFIT trial: testing the hypothesis that trypanocidal therapy is beneficial for patients with chronic Chagas heart disease. Mem Inst Oswaldo Cruz. 2009 Jul;104 Suppl 1:319-24. doi: 10.1590/s0074-02762009000900042.
Related Links
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Population Health Research Institute
Instituto Dante Pazzanese de Cardiologia
Other Identifiers
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CONEP-11394
Identifier Type: OTHER
Identifier Source: secondary_id
BEN01
Identifier Type: -
Identifier Source: org_study_id
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