European Sleep Apnea and Sudden CArdiac Death ProjEct
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 900
- 主要终点
- Assessment of sleep apnea and its treatment on risk of sudden cardiac arrhythmic death by assessing the number of appropriate ICD/CRT-D discharges for each of the groups
研究概览
简要总结
The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions:
- Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death?
- Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients?
- Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant?
- Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?
详细描述
Detailed Study Description
Purpose:
There is strong evidence that patients with ischemic cardiomyopathy have high cardiovascular mortality, including high risk of sudden cardiac death. Sleep apnea is frequently present in patients after myocardial infarction/with ischemic cardiomyopathy (approximately in 50% of patients).
Both central and obstructive sleep apnea are considered as independent risk factors of worsened prognosis in patients with heart failure with reduced ejection fraction (HFrEF). However, there is no evidence from randomized trials yet providing evidence that sleep apnea is an independent risk factor leading to an increase in cardiovascular mortality, including increased risk of sudden cardiac arrhythmic death in patients with ischemic cardiomyopathy. There are also no data from randomized trials assessing if treatment of sleep apnea by positive airway pressure therapy may improve cardiovascular outcomes in these patients, including reduced risk of sudden cardiac death.
Rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death
排除标准
- •Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment
- •Patients with previously implanted ICD/CRT-D device indicated for device replacement
- •Uncontrolled hypertension
- •Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation
- •Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant
- •Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant
- •Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant
- •Severe pulmonary diseases
- •Rejection of participation in the study
- •Pregnancy
- •Age of 80 years and higher in time of ICD/CRT-D implant
结局指标
主要结局
Assessment of sleep apnea and its treatment on risk of sudden cardiac arrhythmic death by assessing the number of appropriate ICD/CRT-D discharges for each of the groups
时间窗: 36 months
次要结局
- Assessment of the effect of sleep apnea and OSA treatment on cardiovascular mortality and morbidity by assessing the incidence of MACE (Major Adverse Cardiovascular Events)(36 months)
- Assessment of incidence of complications resulting from ICD/CRT-D therapy among study groups(36 months)
- Assessment of sleep apnea as a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy(36 months)
- Assessment of effect of sleep apnea treatment on systolic and diastolic functions and neurohumoral profile(36 months)
- Assessment of prevalence of sleep apnea among study population(Time of enrollenment)
研究者
doc. MUDr. Miloš Táborský, CSc., FESC, MBA
Chair, Department of Cardiology, University Hospital Olomouc
University Hospital Olomouc