Prospective Monocentric Cohort Study to Evaluate Predictors for Heart Failure and Sudden Cardiac Death in Patients With Fabry Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Cardiac death
研究概览
简要总结
This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.
详细描述
Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Natural history of Fabry disease has proven poor survival to ages >50 years outlining the importance to evaluate cardiac symptoms and outcomes of patients with Fabry disease.
This study is a prospective cohort study and observes patients since 2001. Through this long-term experience and the relative high number of patients this study is suggested to help estimating the risk of cardiac arrhythmias and sudden cardiac death (SCD) as well as death or heart transplantation due to terminal heart failure.
All patients in treatment in the Fabry Center Wuerzburg (FAZiT) are included in this study if informed consent is provided.
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
- •Fabry disease (genetically confirmed)
- •Signed informed consent
- •18 years and older
排除标准
- •No informed consent
- •Withdrawal of informed consent
结局指标
主要结局
Cardiac death
时间窗: From date of inclusion until the date of first documented event, up to the year 2032
Patients sustaining cardiac death
次要结局
- Heart transplantation(From date of inclusion until the date of first documented event, up to the year 2032)
- Malign Arrhythmias(From date of inclusion until the date of death, up to the year 2032)
研究者
PD Dr. Peter Nordbeck
Head Consultant Cardiology and Chief of Electrophysiology
Wuerzburg University Hospital