Colchicine for Patients With Chagas´ Disease( B1 Stage)

Phase 2

• Conditions: Chagas Disease; Colchicine Resistance
• Interventions: Drug: Colchicine 0.5 MG twice day for one year; Drug: Placebo Oral Tablet

• Registration Number: NCT03704181
• Lead Sponsor: University of Sao Paulo General Hospital

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

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-27
• Study Start: 2018-10-01
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11
• Primary Completion: 2020-12-30
• Study Completion: 2021-01-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colchicine	Colchicine 0.5 MG twice day for one year	colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year
placebo	Placebo Oral Tablet	placebo tablet by mouth every 12 hours, for 1 year pill manufactured to mimic coclchicine 0,5 mg tablet

Primary Outcome Measures

Name	Time	Method
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
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

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

Trial Locations

Locations (1)

Fabio Fernandes; 🇧🇷 São Paulo, Brazil