NCT02154269已完成2 期
Prospective, Double-blind, Randomized, Placebo-controlled Phase II Clinical Trial for Evaluation of G-CSF in Patients With Chronic Chagas Cardiomyopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- NYHA (New York Heart Association) functional class improvement
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chagas' disease confirmed by two serological tests with different methodologies;
- •Diagnosis of Chagas' cardiomyopathy in NYHA functional classes II, III and IV of heart failure;
- •Availability and willingness to participate, given the schedule of the study;
- •Agreement and signing the written form.
排除标准
- •Acute systemic infections
- •Solid neoplasms, myelodysplastic syndrome, acute or chronic myeloid leukemia, confirmed by imaging studies or past medical history;
- •Valvulopathies with hemodynamic consequences;
- •Autoimmune, pulmonary, or degenerative diseases, confirmed by imaging studies or past medical history;
- •Severe renal, hepatic or thyroid dysfunction, confirmed by imaging studies or past medical history;
- •Pregnancy (confirmed by examination of β HCG) or lactation;
- •Known hypersensitivity to G-CSF or to other components of the formula and / or hypersensitivity to proteins derived from E. coli.
研究组 & 干预措施
G-CSF
Experimental
Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
干预措施: Treatment with G-CSF (Granulocyte colony stimulating factor) (Drug)
Saline
Placebo Comparator
Subjects will be randomly assigned to receive saline for five days, during 4 cicles.
干预措施: Placebo saline (Drug)
结局指标
主要结局
NYHA (New York Heart Association) functional class improvement
时间窗: 6, 9 and 12 months after the therapy with G-CSF
All patients will undergo periodic clinical evaluations in order to identify improvement on NYHA classification for heart failure.
次要结局
- Assessment of cardiovascular function measured by transthoracic echocardiography(6 and 12 months after the therapy)
- Evaluation of improvement of quality of life(6 and 12 months after the therapy)
- Assessment of cardiovascular function measured by cardiac magnetic resonance imaging(12 months after therapy)
- Evaluation of functional capacity assessed by treadmill test and by 6-minute walk test(12 months after the therapy)
- Determination of tolerability(1, 5, 13, 17, 25, 29, 37 and 41 days and 3, 6, 9 and 12 months after the therapy)
研究者
Milena Botelho Pereira Soares
PhD
Hospital Sao Rafael
研究点 (1)
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