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COACH: Colchicine for Patients With Chagas´ Disease( B1 Stage)

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03704181
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
60
Enrollment
1
Location
2
Arms
27.2
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Colchicine 0.5 MG twice day for one year
  • Drug: Placebo Oral Tablet
 Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease
Actual Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Jan 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: colchicine

colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year

Drug: Colchicine 0.5 MG twice day for one year
placebo twice day for one year
Other Names:
  • placebo oral tablet

    		•
    Active Comparator: placebo

    placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet

    Drug: Placebo Oral Tablet
    placebo twice day for one year

    Outcome Measures

    Primary Outcome Measures

    1. Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging [1 year]

      myocardial edema quantified in grams or percent of LV mass, myocardial hyperaemia quantified in grams or percent of LV mass

    2. Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging [1 year]

      myocardial fibrosis quantified in grams or percent of LV mass

    Secondary Outcome Measures

    1. Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10 [1 year]

      interleukin-1, interleukin-6, interleukin-8, interleukin-10, ELISA (pg/mL)

    2. Effect of colchicine on inflammatory marker such as TNF-α [1 year]

      TNF-α ELISA (pg/mL)

    3. Effect of colchicine on inflammatory marker such as interferon-gama [1 year]

      Interferon -gama ELISA (pg/mL)

    4. Effect of colchicine on T Cruzi polymerase chain reaction [1 year]

      7500 PCR-Real time System (Life Technologies)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fabio Fernandes São Paulo Brazil 05403000

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    • Principal Investigator: Fabio Fernandes, Md, PHD, Heart Institute, University of São Paulo

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT03704181
    Other Study ID Numbers:
    • 4436/16/102
    First Posted:
    Oct 12, 2018
    Last Update Posted:
    Mar 11, 2019
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Sao Paulo General Hospital
    fibrosis
    Inflammation
    Additional relevant MeSH terms:
    Chagas Disease
    Colchicine

    Study Results

    No Results Posted as of Mar 11, 2019