Central Sleep Apnea Prevalence and Impact on Cognitive Function in Patients with Heart Failure with Reduced or Mildly Reduced Left Ventricular Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Prevalence of CSA in tested HFrEF/HFmrEF patients
研究概览
简要总结
Study to assess the prevalence of central sleep apnea in patients with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF <50%) followed by case-control study to assess the link between central sleep apnea and cognitive function
详细描述
The study will be conducted in two phases: prevalence phase and cognitive phase.
Adult patients with HFrEF/HFmrEF will perform a home sleep apnea test (HSAT). Patients will be assigned to one of the following groups based on their sleep study results: CSA, other SDB, or no SDB. This constitutes the prevalence phase of the study.
The cognitive phase of the study is a case-control study that will assess cognitive function in 20 patients in the CSA group (case) and 20 patients in the no SDB group (control).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with heart failure with reduced or mildly reduced left ventricular ejection fraction (LVEF <50%) at least 3 months prior to enrollment
- •New York Heart Association (NYHA) functional class II-IV
- •Treated and optimized on heart failure guideline directed medical therapy as indicated for at least 4 weeks, including angiotensin receptor-neprilysin inhibitors (ARNI) (or angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blocker (ARB)), aldosterone receptor antagonists, beta-blockers and/or sodium glucose co-transporter 2 (SGLT-2) antagonists
- •Age 50 years or older
- •Signed Institutional Review Board (IRB) or Ethics Committee (EC) approved informed consent
- •In the opinion of the investigator, subject is willing and able to comply with the protocol, including the cognitive function assessment
- •Prevalence Phase
排除标准
- •Hospitalized for heart failure-related complications in the last 4 weeks
- •History of SDB and/or prior or ongoing treatment for SDB or tested for SDB within the prior year
- •Cognitive Phase Inclusion Criteria:
- •AHI ≥ 15 events per hour and CAHI ≥ 50% of total AHI (Case group) or AHI < 5 events per hour (Control group) based on the baseline HSAT
- •Per the patient and investigator, willing and able to postpone CSA treatment until completion of the study assessment visit (Visit 3)
- •Cognitive Phase Exclusion Criteria:
- •Color blindness
- •Currently taking opioids
- •Has taken medications for memory/cognition within the last 3 months (including but not limited to cholinesterase inhibitors and/or glutamate regulators)
- •Cerebrovascular accident (stroke or transient ischemic attack) in the last 12 months
- •Diagnosed with neurological disease including but not limited to history of seizures, meningitis, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis, attention-deficit/hyperactivity disorder (ADHD) or autism.
结局指标
主要结局
Prevalence of CSA in tested HFrEF/HFmrEF patients
时间窗: Through study completion, an average of 1 year
Determine the prevalence of CSA in a contemporary population of HFrEF/HFmrEF patients completing a Home Sleep Apnea Test (using a WatchPAT device) during the prevalence phase of the study.
次要结局
- Difference in cognitive function scores between the HFrEF/HFmrEF CSA and no SDB groups using the CANTAB assessment.(Through study completion, an average of 1 year)