NL-OMON37747已完成4 期
Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure (Major Substudy of SERVE-HF) - SERVE-HF major substudy
Europe ResMed Germany Inc0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The inclusion criteria for the parent SERVE-HF Study apply to the sub-study:
- •Patient must be at least 22 years old
- •Chronic heart failure (at least 12 weeks since diagnosis) according to the currently applicable guidelines
- •LVEF <= 45% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cMRI documented less than 12 weeks before randomization
- •NYHA Class III or IV at the time of inclusion or NYHA Class II with at least one hospitalization for heart failure 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, with no new class of disease modifying drug for more than 4 weeks prior to randomization. In case of no beta blockers or ACE inhibitors/ARB antagonists the reasons must be documented.
- •Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from polygraphy or polysomnography (based on total recording time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula.
- •Patient is able to understand fully the study information and to provide signed informed consent
- •Additional inclusion criteria for the substudy
- •Patients must be at least 22 years old
- •Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with >= 50% central events and a central AHI >=10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements to be performed with nasal cannula
排除标准
- •Patient Exclusion Criteria of the Parent Study
- •Patients will not fulfil any of the parent SERVE-HF Study exclusion criteria:
- •Significant chronic obstructive pulmonary disease with forced expiratory volume within one second < 50% of age and gender normal values, in the last 4 weeks before randomization
- •Oxygen saturation at rest during the day <= 90% at inclusion
- •Current use of positive airways pressure
- •Life expectancy < 1 year for disease unrelated to chronic heart failure
- •Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within 6 months prior to randomization
- •CRT-implantation (either CRT-D or CRT-P) scheduled or within 6 months prior to randomization
- •Transient ischaemic attack or stroke within 3 months prior to randomization
- •Primary haemodynamically 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 randomization
- •Untreated or therapy refractory Restless Leg Syndrome
- •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
- •Additional exclusion criteria for the substudy
- •Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
- •Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomization
研究者
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