跳至主要内容
临床试验/NCT02301689
NCT02301689已完成不适用

SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register

ResMed1 个研究点 分布在 1 个国家目标入组 4,749 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ResMed
入组人数
4,749
试验地点
1
主要终点
Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)

研究概览

简要总结

The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions:

How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?

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

  • •diagnose chronic heart failure, at least 3 months prior to diagnosis
  • •Age 18 years
  • •Signed informed consent

排除标准

  • •Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy
  • •Lack of capacity to consent
  • •persons who are housed on judicial or administrative order in an institution
  • •pregnant and lactating women

结局指标

主要结局

Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5)

时间窗: 5 years

Assess the changes in prevalence of SDB in HF from baseline to 5 years

次要结局

  • Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment(5 years)
  • Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment(5 years)
  • Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours(5 years)
  • Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing(5 years)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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