Colchicine for Patients With Chagas´ Disease( B1 Stage)

Chagas Disease Clinical Trial

— COACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03704181
• Other study ID #: 4436/16/102
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: September 2018
• Source: University of Sao Paulo General Hospital
• Contact: Fabio Fernandes, MD, PHD
• Phone: +55 11 2661 5057
• Email: fabio.fernandes[@]incor.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 5, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease
• Colchicine Resistance

Intervention

Drug:
• Colchicine 0.5 MG twice day for one year
placebo twice day for one year
• Placebo Oral Tablet
placebo twice day for one year

Locations

Country	Name	City	State
Brazil	Fabio Fernandes	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Effect of colchicine on myocardial fibrosis assessed by magnetic resonance imaging	myocardial fibrosis quantified in grams or percent of LV mass	1 year
Secondary	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
Secondary	Effect of colchicine on inflammatory marker such as TNF-a	TNF-a ELISA (pg/mL)	1 year
Secondary	Effect of colchicine on inflammatory marker such as interferon-gama	Interferon -gama ELISA (pg/mL)	1 year
Secondary	Effect of colchicine on T Cruzi polymerase chain reaction	7500 PCR-Real time System (Life Technologies)	1 year