NCT02254382终止不适用
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ResMed
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Change in Apnea-Hypopnea-Index (AHI)
研究概览
简要总结
This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV device; therapy group). The trial will run for 6 months, after which change in echocardiographic parameters of diastolic left ventricular function, sleep and quality of life parameters will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical signs and symptoms of heart failure according to the ESC guidelines
- •Echocardiographic evidence of a preserved systolic left ventricular function (echocardiographic left ventricular ejection fraction > 50%)
- •Polysomnographic evidence of at least moderate sleep-disordered breathing: apnea-hypopnea index (AHI) > 15 / h with ≥ 50% central events and with with a central AHI of ≥ 10/h (AHI based on total sleeping time, TST)
- •BNP or NT-pro BNP ≥ 300 pg / ml
- •NYHA class II or III
- •Patient tolerates the ventilation treatment (1h sample ventilation)
- •Stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy or increasing the dose of diuretics to ≥ 100%)
- •Minimum age of patients of 18 years
- •patient willing to undergo study procedures
- •signed informed consent
排除标准
- •Oxygen saturation (sO2) <92% of the days in peace without O2 therapy, measured baseline (start time) in the pulse oximetry or polysomnography in a cape. BGA (the measurement must be max. Lie back 1 week)
- •Patients, who have a risk professional with symptomatic sleep apnea
- •Known COPD with FEV1 <70%
- •patients with NYHA stadium IV
- •Advanced congenital heart defects
- •pericardial diseases
- •Existing PAP or bi-level therapy (including adaptive servo-ventilation) in the last 3 months
- •Acute cardiac event in the last 3 months
- •BMI ≥ 35kg / m²
- •Pregnant or lactating women
结局指标
主要结局
Change in Apnea-Hypopnea-Index (AHI)
时间窗: 6 months
次要结局
- Change of nocturia(6 months)
- Change of galactin-3(6 months)
- Changes in spiroergometry data (substudy)(6 months)
- Change of echocardiographic parameters of diastolic function(6 months)
- Changes of questionnaires: ESS(6 months)
- Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è(6 months)
- Change of NYHA stage(6 months)
- Change in total sleeping time (TST) determined by parameters of polysomnography(6 months)
- Change in sleep quality determined by parameters of polysomnography(6 months)
- Change in sleep efficacy determined by parameters of polysomnography(6 months)
- Change in 6 minute walk test (MWT)(6 months)
- Change in morning heart rate(6 months)
- Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest(6 months)
- Analysis of compliance data(6 months)
- Changes of questionnaires: MLHFQ(6 months)
- Changes of questionnaires (PHQ9)(6 months)
- Changes of questionnaires (SF12HSQ)(6 months)
- Change in NT-pro BNP and BNP(6 months)
- Changes in blood gas analysis(6 months)
- Hospitalisations (reason)(6 months)
- Change in morning blood pressure(6 months)
- Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)(6 months)
- Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)(6 months)
- Hospitalisations (cumulative length)(6 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Atrial Fibrillation Recurrence in Sleep ApneaSleep ApneaAtrial FibrillationNCT00263757Mayo Clinic25
终止
不适用
Pilot Study of Negative Pressure Sleep Therapy System to Treat Obstructive Sleep ApneaObstructive Sleep ApneaNCT02324790Somnics, Inc.34
已完成
不适用
Positive Airway Pressure Treatment of Obstructive Sleep-disordered Breathing in Hypertensive Disorders of PregnancyHypertensive Disorder of PregnancySleep Apnea, ObstructiveNCT03309826Dr John Kimoff48
终止
不适用
Juno Perth Clinical TrialRespiratory InsufficiencyObesity Hypoventilation SyndromeChronic Obstructive Pulmonary Disease (COPD)Neuromuscular DiseaseUpper Airway ObstructionNCT02317042ResMed25
Unknown
不适用
Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary SyndromeObstructive Sleep ApneaAcute Coronary SyndromeNCT02599298National University of Singapore193