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

University of Sao Paulo General Hospital

Status and phase: Unknown; Phase 2

Conditions: Chagas Disease; Colchicine Resistance

Treatments: Drug: Placebo Oral Tablet; Drug: Colchicine 0.5 MG twice day for one year

Study type: Interventional

Funder types: Other

Identifiers

NCT03704181

4436/16/102

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

colchicine

Experimental group

Description:

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

Treatment:

Drug: Colchicine 0.5 MG twice day for one year

placebo

Active Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet