Impact of Low Flow Nocturnal Oxygen Therapy On Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea - DCC

低流量夜间氧疗对心力衰竭和中枢性睡眠呼吸暂停患者入院和死亡率的影响 - DCC

• 批准号: 10005453
• 负责人: Susan S. Redline
• 金额: $ 105.59万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10005453
• 关键词: Address; Adherence; Adverse effects; Adverse event; Ancillary Study; Archives; Area; Arousal; Biometry; Breathing; Cardiology; Cardiovascular system; Case Report Form; Central Sleep Apnea; Clinical; Clinical Trials; Collaborations; Collection; Communication; Communities; Computer software; Custom; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Management Resources; Data Reporting; Data Set; Databases; Death Rate; Development; Disease; Documentation; Double-Blind Method; EFRAC; Eligibility Determination; Ensure; Epidemiologist; Epidemiology; Event; Evidence based treatment; Failure; Goals; Health; Heart failure; Home environment; Hospital Mortality; Hospitalization; Hospitals; Hypoxemia; Impairment; Informatics; Intervention; Leadership; Long-Term Effects; Manuals; Manuscripts; Measures; Medicine; Methods; Monitor; Moods; Morbidity - disease rate; Multicenter Studies; Neuraxis; Ohio; Online Systems; Outcome; Outcome Study; Oxygen; Oxygen Therapy Care; Oxyhemoglobin; Participant; Patient Recruitments; Patients; Phase; Physicians; Physiological; Polysomnography; Population; Preparation; Procedures; Process; Protocols documentation; Publications; Quality Control; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Reading; Recurrence; Reporting; Research; Research Design; Research Training; Resolution; Resources; Role; Safety; Secure; Services; Site; Sleep; Source; Standardization; Statistical Data Interpretation; Stress; Subgroup; Summary Reports; Supplementation; Support System; Sympathetic Nervous System; System; Testing; Therapeutic; Time; Training; United States National Institutes of Health; Universities; Validation; Walking; Woman; Work; Writing; adjudicate; adjudication; base; clinical practice; cloud based; comorbidity; data dissemination; data management; data quality; data sharing; design; distributed data; diverse data; electronic data capture system; exercise capacity; experience; functional status; heart function; improved; individualized medicine; innovation; member; mortality; novel; participant retention; pragmatic trial; primary outcome; programs; quality assurance; response; secondary endpoint; secondary outcome; service coordination; signal processing; sleep quality; sound; treatment adherence; trial design; uptake; ventilation; web site; web-accessible

Central sleep apnea (CSA), prevalent in approximately 40% of patients with heart failure with reduced ejection fraction (HFrEF), predicts high rates of morbidity, hospitalizations, and mortality. Adverse effects are thought to be attributable to hypoxemia, central nervous system arousal, and sympathetic nervous system activation resulting from episodic breathing disturbances and oxyhemoglobin desaturation. Until recently, the recommended treatment for CSA with HFrEF was adaptive servo-ventilation (ASV). A recent multi-national trial, however, identified an adverse effect of ASV on mortality, leaving a void in therapeutic options for patients with these co-morbid disorders. Although low flow nocturnal oxygen, which provides a physiologically sound intervention for blunting hypoxemia-associated physiological stresses and sympathetic activation, and improves short-term intermediate outcomes in patients with CSA and HFrEF, no large scale study yet has examined its long term impact on clinically important outcomes. We have assembled a team of leaders in cardiology, sleep medicine and clinical trials to conduct a pragmatic trial designed to test the hypothesis that nocturnal oxygen therapy (NOXT) in patients with CSA and HFrEF will reduce mortality and unplanned hospitalizations for worsening HF. Secondary endpoints evaluate other measures of morbidity and mortality, functional status, exercise capacity, quality of life, mood, and sleep quality. Using a double-blinded, randomized design, we will screen 2,450 patients with home sleep studies, estimating that 35% (n=858) will meet study eligibility criteria for CSA. Participants will be randomized to NOXT or sham-NOXT and undergo standardized assessments including a 6 minute walk test, complete validated questionnaires, and will be followed for study outcomes for as long as 4.5 years. Oxygen use and oxygen saturation levels will be centrally monitored using cloud-based software. Primary outcomes will be assessed using a time to first event analysis, and secondarily as recurrent event rates. Highly efficient methods for data capture and monitoring and project management will be deployed. Novel physiological markers of ventilation during sleep will be derived to identify responsive subgroups. This rigorous yet practical design will provide pivotal trial data needed to identify the role of a potentially beneficial and acceptable therapy which has yet to be tested on a large scale in a population with high morbidity and mortality, for a condition where there is no current evidence-based treatment. The sleep assessments and interventions are practically designed with the objective of facilitating their rapid uptake and use by the cardiology and sleep communities. This Data Coordinating Center application is to provide the study comprehensive, responsive, and innovative data management and study coordination services, biostatistical analysis, rigorous adjudication of study outcomes, and centralized sleep analysis and oxygen monitoring to ensure that the study meets its milestones.

中枢性睡眠呼吸暂停（CSA），在约40%的射血减少的心力衰竭患者中普遍存在 分数（HFrEF）预测高发病率，住院率和死亡率。不良影响被认为是 可归因于低氧血症、中枢神经系统唤醒和交感神经系统激活 由间歇性呼吸紊乱和氧合血红蛋白去饱和引起。直至最近缅甸国内 CSA伴HFrEF的推荐治疗是适应性伺服通气（ASV）。最近的一次多国审判， 然而，确定了ASV对死亡率的不利影响，为患有以下疾病的患者留下了治疗选择的空白 这些共病性疾病虽然低流量夜间氧气，这提供了一个生理健全的 用于减弱低氧血症相关的生理应激和交感神经激活的干预，并改善 CSA和HFrEF患者的短期中期结局，尚未有大规模研究对其进行评估。 对临床重要结局的长期影响。我们召集了一个心脏病学，睡眠， 医学和临床试验，进行一项务实的试验，旨在测试的假设，夜间氧气 CSA和HFrEF患者的NOXT治疗将降低死亡率和计划外住院， HF恶化。次要终点评价了发病率和死亡率、功能状态， 运动能力、生活质量、情绪和睡眠质量。采用双盲随机设计，我们将 通过家庭睡眠研究筛选2,450例患者，估计35%（n = 858）将符合以下研究合格标准： CSA。受试者将被随机分配至NOXT组或假NOXT组，并接受标准化评估，包括 6分钟步行测试，完成经验证的问卷，并将随访研究结果， 4.5年氧气使用和氧饱和度水平将使用基于云的软件进行集中监测。 将使用至首次事件时间分析评估主要结局，其次评估复发事件率。 将采用高效的数据采集和监测及项目管理方法。小说 将导出睡眠期间通气的生理标记以识别响应亚组。这种严格 然而，实际的设计将提供关键的试验数据，需要确定的作用， 可接受的治疗方法尚未在发病率高的人群中进行大规模测试， 死亡率，对于目前没有循证治疗的情况。睡眠评估和 干预措施的实际设计目标是促进心脏病学的快速吸收和使用 睡眠社区此数据协调中心应用程序将提供全面的研究， 响应迅速，创新的数据管理和研究协调服务，生物统计分析，严格的 研究结果的裁定，以及集中睡眠分析和氧气监测，以确保研究 达到它的里程碑。