Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure - SERVE-HF

ResMed Ltd., Australia0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patients must be at least 22 years old
•Chronic heart failure (at least 12 weeks since diagnosis) according to the current applicable guidelines (ESC), ACC/AHA)
•Left ventricular systolic dysfunction (LVEF <=45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging) documented less than 12 weeks before randomisation
•NYHA class III or IV at the time of inclusion or NYHA class II with at least one hospitalization for HF in the last 24 months
•No hospitalization for heart failure for at least 4 weeks prior to inclusion
•Optimised medical treatment according to applicable guidelines (see Appendix X) with no new class of disease modifying drug for more than 4 weeks prior to randomisation. In case of no beta blockers or ACE inhibitors/ ARB antagonists the reasons must be documented
•SDB (AHI > 15 events/hour with >= 50% central events and a central AHI >= 10 events/hour, derived from polygraphy or polysomnography (based on total recording time (TRT)), documented less than 4 weeks before randomisation. Flow measurement has to be performed with nasal cannula
•Patient is able to fully understand study information and signed informed consent

•Significant COPD with Forced Expiratory Volume within one second (FEV1) <50% (European Respiratory Society criteria) in the last four weeks before randomisation
•Oxygen saturation at rest during the day <=90% at inclusion
•Current use of Positive Airway Pressure (PAP) - therapy
•Life expectancy < 1 year for diseases unrelated to chronic HF
•Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
•CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months prior to randomisation
•Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
•Primary hemodynamically significant uncorrected valvular heart disease, obstructive or
•regurgitant, or any valvular disease expected to lead to surgery during the trial
•Acute myocarditis/pericarditis within 6 months prior to randomisation
•Untreated or therapy refractory Restless legs-Syndrome (RLS) according to criteria listed in
•Appendix IX at the time of study entry
•Patients for whom the use of AutoSet CS / S9 VPAP Adapt may be contra-indicated according to
•the user*s manual of the device used
•Pregnancy

发起方

ResMed Ltd., Australia