Physiological Study to Predict Successful Sleep Apnea Treatment With Acetazolamide in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)
研究概览
简要总结
The ultimate goal is to improve our understanding of the pathophysiology and resistance to effective treatment of sleep disordered breathing in patients with heart failure, with a focus on selecting patients that will benefit specifically from acetazolamide treatment.
The study addresses three primary hypotheses: 1) Acetazolamide treatment will reduce the apnea-hypopnea index and improve markers of heart-failure severity in heart-failure patients with sleep apnea. 2) Acetazolamide will provide the greatest improvement in patients with the most severe ventilatory control instability (strongest chemoreflex response to carbon dioxide; highest loop gain). 3) Acetazolamide will act primarily via stabilizing ventilatory control (reducing loop gain), rather than via improvement to upper airway anatomy, pulmonary congestion, and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •severe obstructive respiratory disease
- •unstable heart failure status
- •recent use of positive airway pressure therapy
- •current use of opioids, benzodiazepines
- •severe kidney disease
- •severe anemia
研究组 & 干预措施
Acetazolamide
干预措施: Acetazolamide (Drug)
Sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)
时间窗: 1 week
The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.
次要结局
- Ventilatory Chemoreflex Sensitivity, "Loop Gain" Using Carbon Dioxide Pulses(1 week)
- Sympathetic Activity (Urinary Norepinephrine)(1 week)
- Left-atrial Volume(1 week)
- Brain Natriuretic Peptide (NT-proBNP)(1 week)
- Pittsburgh Sleep Quality Index(1 week)
研究者
David Andrew Wellman
Associate Professor of Medicine
Brigham and Women's Hospital