A Prevalence and Incidence Study Investigating the Burden of Atrial and Ventricular Arrhythmias in Patients With Hypertrophic Cardiomyopathy and Sleep Apnea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Prevalence of Obstructive Sleep Apnea (OSA).
研究概览
简要总结
The investigators are trying to find out how common sleep apnea is in hypertrophic cardiomyopathy. The purpose of this study is to see if sleep apnea is common in hypertrophic cardiomyopathy and if its presence is associated with changes in the functioning of the body. The investigators want to determine if sleep apnea is associated with electrical disorders of the heart in patients with hypertrophic cardiomyopathy.
详细描述
Participants will be healthy volunteers or subjects with the diagnosis of hypertrophic cardiomyopathy (HCM). All patients will a undergo a one time; medical history, physical examination, questionnaires, sleep observation in hospital, blood and urine samples, ultrasound scan of the heart, paced breathing test, ultrasound of brachial artery in the arm, MRI of the heart & 48 hour ECG Holter monitoring. Comparison between the normal volunteers and subjects with HCM will be made.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prevalence of Obstructive Sleep Apnea (OSA).
时间窗: Approximately 2 years.
Measured by the Apnea-hypopnea index (AHI). The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, sleep apnea is diagnosed if an AHI ≥5 events/hour.
Determine the severity of Sleep Apnea.
时间窗: Approximately 2 years.
The severity of OSA is classified based on the AHI as follows: None/Minimal: AHI \< 5 per hour, Mild: AHI ≥ 5, but \< 15 per hour, Moderate: AHI ≥ 15, but \< 30 per hour, Severe: AHI ≥ 30 per hour.
Differences in Autonomic Regulation.
时间窗: Approximately 2 years.
In persons with hypertrophic cardiomyopathy and sleep apnea vs. those without sleep apnea.
Prevalence of atrial arrhythmias.
时间窗: Approximately 2 years.
Investigators will determine prevalence of atrial arrhythmias, based on prior ECG documented atrial arrhythmias at any timepoint prior to enrolment and up to 4 weeks after the study date. Participants will also have a 48h ECG (extended Holter) recorder attached to screen for atrial arrhythmias.
Incidence of atrial arrhythmias.
时间窗: Approximately 5 years.
Frequency of ventricular arrhythmias.
时间窗: Approximately 5 years.
Investigators will prospectively follow patients with hypertrophic cardiomyopathy to determine the frequency of ventricular arrhythmias in those with vs those without sleep apnea.
次要结局
- Identify novel biomarkers(Approximately 5 years)
- Investigate the association of sleep apnea with atrial and ventricular fibrosis(Approximately 7 years)
研究者
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic