Colchicine for Patients With Chagas´ Disease( B1 Stage)
NCT ID: NCT03704181
Last Updated: 2019-03-11
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2018-10-01
2021-01-05
Brief Summary
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Forty patients will receive colchicine while twenty patients will receive placebo
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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colchicine
colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year
Colchicine 0.5 MG twice day for one year
placebo twice day for one year
placebo
placebo tablet by mouth every 12 hours, for 1 year
pill manufactured to mimic coclchicine 0,5 mg tablet
Placebo Oral Tablet
placebo twice day for one year
Interventions
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Colchicine 0.5 MG twice day for one year
placebo twice day for one year
Placebo Oral Tablet
placebo twice day for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to swallow tablets
Exclusion Criteria
* diabetes mellitus,
* valvular disease,
* creatinine clearance \<30 ml / kg / min
* contraindication to perform cardiac magnetic resonance imaging
* use of angiotensin converting enzyme inhibitors, angiotensin II receptor blockers and aldosterone blockers
* previous use of benzonidazole
18 Years
70 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Fabio Fernandes, Md, PHD
Role: PRINCIPAL_INVESTIGATOR
Heart Institute, University of São Paulo
Locations
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Fabio Fernandes
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4436/16/102
Identifier Type: -
Identifier Source: org_study_id
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