Effects of Adaptive Servoventilation in Patients With Systolic Heart Failure and Sleep-Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Influence of adaptive servoventilation on heart failure parameters including event free survival
研究概览
简要总结
Prospective, follow-up registry of heart failure patients with or without sleep-disordered breathing (SDB). To test the hypothesis that treatment of nocturnal central sleep apnea with Cheyne-Stokes respiration by adaptive servoventilation (ASV) improves symptoms, cardiac performance and event-free survival.
详细描述
The study is intended to investigate therapeutic effects of adaptive servoventilation in patients with sleep-disordered breathing and chronic heart failure. These effects include short-/long-term effects on
- symptoms and quality of life
- physical and cardiac performance (6min walking test, cardiopulmonary exercise testing)
- echocardiographic parameters
- arrhythmias
- NT-proBNP
- Respiratory stability (blood gases, rebreathing test, VE/VCO2-slope in cardiopulmonary exercise testing)
- Compliance with ASV therapy
- Event free survival (death, heart transplantation, assist device implantation)
All of these data are also obtained in patients who basically meet the inclusion criteria but in whom sleep-disordered breathing was excluded by means of cardiorespiratory polygraphy or polysomnography and in patients with sleep-disordered breathing who do not undergo adaptive servoventilation for various reasons.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Stable heart failure NYHA ≥ II
- •without sleep-disordered breathing (apnea-hypopnea-index <5/h) and those with moderate to severe central sleep apnea (apnea-hypopnea index ≥ 15/h) with or without adaptive servoventilation therapy
排除标准
- •Cardiac resynchronization or pacemaker implantation within the last 6 months
- •Significant COPD with an forced expiratory one-second capacity relative to vital capacity (FEV1/VC)< 70% (GOLD III)
- •Respiratory insufficiency requiring long-term oxygen therapy
- •Daytime hypercapnia at rest (pCO2 > 45 mmHg)
- •Current ventilation therapy
- •Cardiac surgery, PCI, myocardial infarction, unstable angina, TIA or stroke within 12 weeks prior to randomization
- •Acute myocarditis within 6 months prior to randomization
- •Pregnancy
结局指标
主要结局
Influence of adaptive servoventilation on heart failure parameters including event free survival
时间窗: Time frame for event free survival analysis is up to 8 years
This prospective registry includes heart failure patients with or without accompanied sleep-disordered breathing and investigates its influence on symptoms, cardiac function and performance, quality of life and outcome.
次要结局
未报告次要终点
研究者
Olaf Oldenburg
Senior cardiologist
Ruhr University of Bochum