A Prospective Incident Study of Arrhythmias in Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
研究概览
简要总结
The purpose of this research study is to understand more about various heart rhythms (electrical problems) in persons with hypertrophic cardiomyopathy with and without sleep apnea.
详细描述
Adult patients with hypertrophic cardiomyopathy and without known atrial fibrillation or pacemaker/implantable cardiac defibrillation will undergo implantable loop recorder implantation. No direct interventions will be performed. Prospective observation of atrial and ventricular arrhythmia incidence and burden will be assessed, with additional analyses performed based on the presence or absence of obstructive sleep apnea.
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
- •Currently or previously enrolled in 17-003514 and 16-009474
- •Adults age >18 years-old with a diagnosis of hypertrophic cardiomyopathy
- •Both sexes
- •Able to consent
排除标准
- •Vulnerable study population
- •Known atrial fibrillation or flutter (with the exception of post-operative atrial fibrillation)
- •Pacemaker/ICD implantation
- •Pregnancy
结局指标
主要结局
Ventricular arrhythmia incidence in hypertrophic cardiomyopathy
时间窗: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed ventricular arrhythmias in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation recurrence in hypertrophic cardiomyopathy
时间窗: Final recurrence rate to be calculated at study conclusion, after 3 years of rhythm monitoring.
Determine the frequency of recurrent atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
Atrial fibrillation incidence in hypertrophic cardiomyopathy
时间窗: Final incidence to be calculated at study conclusion, after 3 years of rhythm monitoring.
Define the incidence ratio of newly diagnosed atrial fibrillation in hypertrophic cardiomyopathy, with and without sleep apnea
次要结局
未报告次要终点
研究者
Jeffrey B. Geske
Principal Investigator
Mayo Clinic