Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation - a Prospective Single Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.
详细描述
Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation, as this topic is hardly studied yet and previous reports suggest changes in the entity of sleep-disordered breathing through heart transplantation. The circumstances and the impact of sleep-disordered breathing or residuals in heart transplant patients is not well understood yet and will be subject of this study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •End-stage heart failure patients assigned and eligible for heart transplantation
排除标准
- •heart failure patients not eligible for heart transplantation
结局指标
主要结局
Apnea Hypopnea Index
时间窗: 30 days after heart transplantation
Change in Apnea Hypopnea Index (AHI /h) before and after heart transplantation
次要结局
- Hypopnea Index(30 days after heart transplantation)
- Time SaO2 < 90 (%)(30 days after heart transplantation)
- Respiration cycle length(30 days after heart transplantation)
- Right heart catheter(30 days after heart transplantation)
- Apnea Index(30 days after heart transplantation)
- Health Questionnaires(30 days after heart transplantation)
- Oxygen Desaturation Index(30 days after heart transplantation)
- Blood gas analysis(30 days after heart transplantation)
研究者
Henrik Fox, MD
Cardiologist
Heart and Diabetes Center North-Rhine Westfalia