A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 732
- 试验地点
- 98
- 主要终点
- The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization.
研究概览
简要总结
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months
- •Left Ventricular Ejection Fraction ≤ 45 %
- •Optimal medical therapy for heart failure
- •No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization
- •Sleep apnea with an AHI ≥
- •Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness
- •Written informed consent
排除标准
- •Heart failure due to primary valvular heart disease
- •Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease
- •Hypertrophic obstructive or restrictive or post partum cardiomyopathy
- •Exercise capacity limited by class IV angina pectoris
- •Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization
- •Active myocarditis
- •Planned AICD or CRT
- •Presence of a left-ventricular assist device
- •Transplanted heart or expected to receive a transplanted heart within the next 6 months
- •Pregnancy
- •Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
- •A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study
- •Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance)
- •Any contraindication to ASV therapy as detailed in the device provider manual
结局指标
主要结局
The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization.
时间窗: The expected study follow-up period is five years
The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years.
次要结局
- Time to death from any cause(The expected study follow-up period is 5 years)
- Number of cardiovascular hospitalizations per year of follow-up(The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years)
- Changes in left ventricular function(6 months from randomization)
- Changes in Quality of life assessments(Assessments made at baseline, 1, 6, 12 and every 6 months thereafter)
- Number of days alive not hospitalized(Time from randomization to censoring (death, primary event or end of study))
- Changes in plasma BNP levels(6 months from randomization)
- Changes in 6 minute walk test distance(6 months from randomization)
- Percentage of patients with changes in stages of heart failure and functional class(Values obtained at study termination will be compared to those obtained at randomization)
- Changes in apnea/hypopnea index(1 month from randomization)
- Cardiac resynchronization therapy or defibrillator implantations(Average number of days until first cardiac resynchronization or first defibrillator implantation)
研究者
Douglas Bradley
Study Chairman
Toronto Rehabilitation Institute