BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

Last updated: February 27, 2020
Sponsor: Population Health Research Institute
Overall Status: Completed

Phase

3

Condition

Cardiac Disease

Cardiovascular Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00123916
BEN01
CONEP-11394
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consenting patients (between 18 and 75 years of age) with serological evidence ofChagas infection (any combination of 2 positive tests) and that have one or more ofthe following:

  • Abnormal electrocardiogram with at least two components (complete RBBB or LBBB; leftanterior or posterior fascicular block; ventricular premature beat; first degreeatrioventricular [AV] block; Mobitz type I AV block; sinus bradycardia; primary ST-Tchanges; 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 ventricularsystolic function or increased left ventricular and diastolic diameter on 2D-Echo.

Exclusion

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 dilatedcardiomyopathy

  • Previous treatment with antitrypanosomal agents or an accepted indication forantiparasitic 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

Study Design

Total Participants: 2854
Study Start date:
November 01, 2004
Estimated Completion Date:
August 31, 2015

Study 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.

Connect with a study center

  • BENEFIT Ivestigational Site

    Ciudad Autónoma de Buenos Aires, Apital Federal 3556
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Belén De Escobar, Buenos Aires 1753
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Escobar, Buenos Aires 1753
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Isidro Casanova, Buenos Aires 1282
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    San Juan, Buenos Aires 1625
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Santiago del Estero, Buenos Aires 4200
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Ciudad Autónoma de Buenos Aires, Capital Federal 1063
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    San Fernando del Valle de Catamarca, Catamarca
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Charata, Chaco H3730AVI
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Paraná, Entre Rios 3100
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Paraná, Entre Rios 3100
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    San Salvador de Jujuy, Jujuy 4600
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Corrientes, Rosario, Santa Fe 3400
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Añatuya, Santiago Del Estero 3760
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Añatuya, Santiago del Estero 3760
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Santiago Del Estero, Sgo. Del Estero 4200
    Argentina

    Site Not Available

  • BENEFIT Ivestigational Site

    Ciudad Autónoma de Buenos Aires, apital Federal 3556
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Buenos Aires,
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Salta, A4406CLA
    Argentina

    Site Not Available

  • BENEFIT Investigational Site

    Tupiza, Potosi
    Bolivia

    Site Not Available

  • BENEFIT Investigational Site

    Salvador, Bahaia 40110-909
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Carmo, Belo Horizonte 30130-690
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Brasília, Brazilian Federal District 70658-700
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Brasília, Brazilian Federal District 70658-700
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Goiânia, GO 74110-020
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Goiânia, GO 74110-010
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Uberlandia, MG 38025-440
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Uberlândia, MG 38400-299
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Uberlândia, MG 38400-299
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Uberaba, Minas Gerais 38010-160
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Curitiba, Parana 80060-900
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Recife, Pernambuco 50100-130
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Pelotas, Rio Grande Do Sul 96015-290
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Ribeirão Preto, São Paulo 14048-900
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    São José do Rio Preto, São Paulo 15015-210
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Campinas, São Paulo 13059-740
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Ribeirão Preto, São Paulo 14048-900
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    São José do Rio Preto, São Paulo 15090-000
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Votuporanga, São Paulo 15500-003
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Rio de Janeiro, 21040-360
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    São Paulo, 04012-909
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    São Paulo, 04012-909
    Brazil

    Site Not Available

  • BENEFIT Investigational Site

    Bogota, Bogotá
    Colombia

    Site Not Available

  • BENEFIT Investigational Site

    San Gil, Santander
    Colombia

    Site Not Available

  • BENEFIT Ivestigational Site

    San Salvador,
    El Salvador

    Site Not Available

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