Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 509
- 试验地点
- 18
- 主要终点
- Time to first event of all cause mortality or all cause hospitalization
研究概览
简要总结
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).
详细描述
The prevalence of Central Sleep Apnea (CSA) and/or Cheyne-Stokes Respiration (CSR) in patients with Chronic Heart Failure (HF) is 15-46% and it is associated with worse prognosis. Adaptative Servo-Ventilation (ASV) suppresses sleep apnoea and reduces hyperventilation, and is more effective than continuous positive airway pressure (CPAP) for treating CSA/CSR. Short-term studies show that ASV improves cardiac function and quality of life in CHF patients.
The SERVE HF multinational randomized trial is assessing the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone in symptomatic CHF patients with altered Left Ventricular Ejection Fraction and predominant CSA/CSR. The FACE study is a French prospective, multicentre, observational cohort that will provide complementary data to SERVE HF trial by characterizing CHF population eligible for ASV indications and evaluating the treatment management on long term follow-up of CHF patients with CSA/CSR in routine practice.
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
- •Adult Patient with Chronic Heart Failure
- •Central Sleep Apnea requiring ASV therapy
排除标准
- •Contra-indications to ASV therapy
- •Respiratory Failure or Hypercapnia inconsistent with ASV therapy
结局指标
主要结局
Time to first event of all cause mortality or all cause hospitalization
时间窗: 2 years
Time to first event of all cause mortality or unplanned hospitalization for worsening heart failure
时间窗: 2 years
Time to first event of cardiovascular mortality or unplanned hospitalization for worsening heart failure
时间窗: 2 years
次要结局
- Changes in CHF stage by evaluating NYHA (New York Heart Association) class as compared to baseline(2 years)
- Changes in LVEF (Left Ventricular Ejection Fraction) as compared to baseline(2 years)
- ASV Compliance(2 years)
- Changes in Quality Of Life by measuring Minnesota score as compared to baseline(2 years)
- Changes in BNP (B-type Natriuretic Peptide) rates as compared to baseline(2 years)
- Time to hospitalization due to deterioration of heart failure or cardiovascular death(2 years)
- Time to hospitalization for other reasons or death(2 years)
- Changes in Systolic and diastolic Blood Pressure(2 years)
- Changes in AHI (Apnea Hypopnea Index) as compared to baseline(2 years)
- Time until death(2 years)
- Time to non cardiovascular death(2 years)
- Time to cardiovascular death(2 years)
- Time to hospitalization for cardiovascular cause or cardiovascular death(2 years)
- Changes in Heart Rhythm as compared to baseline(2 years)
- Changes in renal function as compared to baseline(2 years)
- Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline(2 years)
- Changes in medical treatment as compared to baseline(2 years)