Effect of Colchicine on Inflammation and Myocardial Fibrosis Assessed by Magnetic Resonance Imaging in Patients With Chagas' Heart Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and serological diagnosis of Chagas´disease ( Stage B1)
- •Must be able to swallow tablets
排除标准
- •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
研究组 & 干预措施
colchicine
colchicine 0,5 milligram tablet by mouth every 12 hours, for 1 year
干预措施: Colchicine 0.5 MG twice day for one year (Drug)
placebo
placebo tablet by mouth every 12 hours, for 1 year
pill manufactured to mimic coclchicine 0,5 mg tablet
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Effect of colchicine on myocardial inflammation assessed by magnetic resonance imaging
时间窗: 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
时间窗: 1 year
myocardial fibrosis quantified in grams or percent of LV mass
次要结局
- Effect of colchicine on inflammatory marker such as interferon-gama(1 year)
- Effect of colchicine on inflammatory markers such as interleukin-1, interleukin-6, interleukin-8, interleukin-10(1 year)
- Effect of colchicine on inflammatory marker such as TNF-α(1 year)
- Effect of colchicine on T Cruzi polymerase chain reaction(1 year)