NCT02254382终止不适用
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
ResMed2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 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
研究组 & 干预措施
Adaptive servo ventilation (ASV)
Experimental
This group will receive ventilation therapy (AutoSet CS, ASV device)
干预措施: Adaptive servo ventilation (ASV) (Device)
结局指标
主要结局
Change in Apnea-Hypopnea-Index (AHI)
时间窗: 6 months
次要结局
- Changes in spiroergometry data (substudy)(6 months)
- Change in morning heart rate(6 months)
- Change in morning blood pressure(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)
- 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)
- 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)
- Change of nocturia(6 months)
- Change of galactin-3(6 months)
研究者
研究点 (2)
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