Colchicine for Patients With Chagas´ Disease( B1 Stage) (COACH)
Primary Purpose
Chagas Disease, Colchicine Resistance
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Colchicine 0.5 MG twice day for one year
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Chagas Disease focused on measuring fibrosis, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Clinical and serological diagnosis of Chagas´disease ( Stage B1)
- Must be able to swallow tablets
Exclusion Criteria:
- myocardial infarction or coronary artery disease,
- 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
Sites / Locations
- Fabio FernandesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
colchicine
placebo
Arm Description
colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year
placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet
Outcomes
Primary Outcome Measures
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass
Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging
myocardial fibrosis quantified in grams or percent of LV mass
Secondary Outcome Measures
Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10
interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL)
Effect of colchicine on inflammatory marker such as TNF-α
TNF-α ELISA (pg/mL)
Effect of colchicine on inflammatory marker such as interferon-gama
Interferon -gama ELISA (pg/mL)
Effect of colchicine on T Cruzi polymerase chain reaction
7500 PCR-Real time System (Life Technologies)
Full Information
NCT ID
NCT03704181
First Posted
September 27, 2018
Last Updated
March 8, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03704181
Brief Title
Colchicine for Patients With Chagas´ Disease( B1 Stage)
Acronym
COACH
Official Title
Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
January 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluate the addition of colchicine in the treatment of patients with Chagas´disease.
Forty patients will receive colchicine while twenty patients will receive placebo
Detailed Description
Chagas disease is considered one of the main cause of dilated cardiomyopathy in Latin America. The histopathological characteristics of Chagas' disease are the presence of myocarditis, destruction of heart fibers, and severe myocardial fibrosis. Colchicine had a protective effect on myocardium, indicated by decreased interstitial myocardial fibrosis and attenuated myocardial inflammation. It is an inflammatory cause of cardiomyopathy and myocardial fibrosis is the hallmark of this disease. Colchicine is a drug used in inflammatory diseases, and could also act on myocardial remodeling interfering in the synthesis of collagen
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chagas Disease, Colchicine Resistance
Keywords
fibrosis, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
colchicine
Arm Type
Experimental
Arm Description
colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
placebo tablet by mouth every 12 hours, for 1 year
pill manufactured to mimic coclchicine 0,5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 MG twice day for one year
Other Intervention Name(s)
placebo oral tablet
Intervention Description
placebo twice day for one year
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
placebo twice day for one year
Primary Outcome Measure Information:
Title
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
Description
myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass
Time Frame
1 year
Title
Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging
Description
myocardial fibrosis quantified in grams or percent of LV mass
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10
Description
interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL)
Time Frame
1 year
Title
Effect of colchicine on inflammatory marker such as TNF-α
Description
TNF-α ELISA (pg/mL)
Time Frame
1 year
Title
Effect of colchicine on inflammatory marker such as interferon-gama
Description
Interferon -gama ELISA (pg/mL)
Time Frame
1 year
Title
Effect of colchicine on T Cruzi polymerase chain reaction
Description
7500 PCR-Real time System (Life Technologies)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and serological diagnosis of Chagas´disease ( Stage B1)
Must be able to swallow tablets
Exclusion Criteria:
myocardial infarction or coronary artery disease,
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabio Fernandes, MD, PHD
Phone
+55 11 2661 5057
Email
fabio.fernandes@incor.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Buck, PHD
Phone
+55 11 2661 5346
Email
carpaula@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Fernandes, Md, PHD
Organizational Affiliation
Heart Institute, University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fabio Fernandes
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Fernandes, MD
Phone
+55 11 997681946
Email
fabio.fernandes@incor.usp.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Colchicine for Patients With Chagas´ Disease( B1 Stage)
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