NCT02252653已完成不适用
DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 1,010 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,010
- 试验地点
- 1
- 主要终点
- Proportion of patients with of Transthyretin (TTR) mutations
研究概览
简要总结
The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females >18 years old
- •History of evidence suggestive of cardiac amyloidosis
- •Subject is willing and able to comply with protocol required assessments and provide written informed consent
排除标准
- •Known diagnosis of primary (AL) amyloidosis
- •Known diagnosis of hereditary cardiomyopathy or cardiomyopathy due to aortic stenosis
- •Patient is currently pregnant
结局指标
主要结局
Proportion of patients with of Transthyretin (TTR) mutations
时间窗: Baseline
Blood will be sequenced for the presence of TTR gene mutations
次要结局
- Assessment of the presence of amyloid in tissue(Day 30)
- Quantification of biomarkers of cardiac function in serum(Day 30)
- Measurement of echocardiogram parameters(Day 30)
- New York Heart Association (NYHA) Functional Classification(Day 30)
- Results from 6-Minute Walk Test(Day 30)
研究者
研究点 (1)
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