NCT03704181

Colchicine for Patients With Chagas´ Disease( B1 Stage)

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chagas Disease
• Colchicine Resistance

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG twice day for one year	placebo twice day for one year
DRUG	Placebo Oral Tablet	placebo twice day for one year

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-12-30
• Completion: 2021-01-05
• First posted: 2018-10-12
• Last updated: 2019-03-11

Locations

1 site across 1 country: Brazil