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

Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease

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

Study Overview

• Status: Unknown
• Conditions: Chagas Disease; Colchicine Resistance
• Intervention / Treatment: Drug: Colchicine 0.5 MG twice day for one year; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fabio Fernandes, MD, PHD; Phone Number: +55 11 2661 5057; Email: fabio.fernandes@incor.usp.br
• Study Contact Backup: Name: Paula Buck, PHD; Phone Number: +55 11 2661 5346; Email: carpaula@incor.usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Fabio Fernandes
    • Contact: Fabio Fernandes, MD; Phone Number: +55 11 997681946; Email: fabio.fernandes@incor.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging	myocardial fibrosis quantified in grams or percent of LV mass	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year
Effect of colchicine on inflammatory marker such as TNF-α	TNF-α ELISA (pg/mL)	1 year
Effect of colchicine on inflammatory marker such as interferon-gama	Interferon -gama ELISA (pg/mL)	1 year
Effect of colchicine on T Cruzi polymerase chain reaction	7500 PCR-Real time System (Life Technologies)	1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Fabio Fernandes, Md, PHD, Heart Institute, University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): January 5, 2021

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; fibrosis
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Chagas Disease; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 4436/16/102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No