The Natural History of Arrhythmogenic Cardiomyopathy With Pathogenic Plakophilin-2 Variants (PKP2-ACM): An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Heart rhythm and rate monitoring measures
研究概览
简要总结
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
详细描述
This is an observational study with both retrospective and prospective data collection. The study is designed to describe the natural history of PKP2-ACM including the signs and symptoms, key clinical events, and impact of the disease on quality of life. A hybrid (retrospective and prospective data collection) approach is being taken with the aim of achieving robust and longitudinal data generation.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Heart rhythm and rate monitoring measures
时间窗: 36 months
Evaluate electrophysiology as assessed by heart rate and rhythm
Cardiac biomarkers
时间窗: 36 months
Evaluate heart health as assessed by cardiac biomarkers
次要结局
- Characterize cardiovascular events(36 months)
- Evaluate patient reported outcomes and quality of life measures(36 months)
- Interrogate ICDs(36 months)
- Evaluate changes in health status(36 months)
- Cardiac Structure and Performance(36 months)
- Evaluate genetics(Cross sectional)