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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00123916 |
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Date of registration:
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21/07/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
BENEFIT |
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Scientific title:
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Benznidazole Evaluation for Interrupting Trypanosomiasis - The BENEFIT Trial |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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2854 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00123916 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Bolivia
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Brazil
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Canada
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Colombia
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El Salvador
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Contacts
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Name:
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Carlos Morillo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Population Health Research Institute - McMaster University |
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Name:
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Jose Antonio Marin-Neto, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Sao Paulo |
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Name:
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Salim Yusuf, MD, DPh |
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Address:
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Telephone:
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Email:
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Affiliation:
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Population Health Research Institute - McMaster University |
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Name:
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Fernando Rosas, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundacion Clinica Shaio, Bogota, Colombia |
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Name:
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Sergio Sosa-Estani, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Argentina National Coordinator - CenDIE, Argentina |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Disease
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Chagas Disease
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Trypanosomiasis
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Intervention(s)
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Drug: Placebo
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Drug: Benznidazole
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Primary Outcome(s)
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Composite of First of cardiovascular events: Death, Resuscitated Cardiac Arrest, Sustained VentricularTachycardia, New/worsening Heart Failure, New Pacemaker/ICD, Stroke/TIA or other Embolic Events, Cardiac Transplant.
[Time Frame: through study completion, an average of 5 years]
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Secondary Outcome(s)
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Progression of New York Heart Association (NYHA) functional class by at least one category
[Time Frame: through study completion, an average of 5 years]
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Determination of the efficacy of benznidazole in patients with Chronic Chagas heart disease based on a 50% reduction in both qualitative and quantitative PCR.
[Time Frame: through study completion, an average of 5 years]
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New 12 lead ECG alterations (complete bundle branch block, fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc).
[Time Frame: through study completion, an average of 5 years]
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New 12 lead electrocardiogram (ECG) alterations (complete bundle branch block; fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc.)
[Time Frame: through study completion, an average of 5 years]
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Evaluation of safety (adverse events: dermatitis, peripheral neuropathy, gastro-intestinal intolerance, leucopenia [2500 x 10^9 L]), tolerance and adherence to treatment
[Time Frame: through study completion, an average of 5 years]
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New development of any of the following echo changes, segmental wall motion abnormalities, ventricular aneurysm, reduction in LV ejection fraction >5%, increase in LVDD> 5 mm compared to baseline.
[Time Frame: through study completion, an average of 5 years]
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Progression of NYHA functional class by at least one category
[Time Frame: through study completion, an average of 5 years]
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Safety and tolerability of benznidazole
[Time Frame: through study completion, an average of 5 years]
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Secondary ID(s)
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BEN01
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CONEP-11394
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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