Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Adherence (hours/night)
研究概览
简要总结
This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients 18 years or older
- •Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
- •Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:
- •Dyspnea at rest or with minimal exertion AND
- •Treatment with at least one dose of IV diuretic or ultrafiltration AND
- •At least two of the following signs and symptoms:
- •i. Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level:
- •No current AFib: BNP≥100 pg/mL or NT pro-BNP≥300 pg/mL OR
- •Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL
- •Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
- •Patient is able to fully understand study information and sign informed consent
排除标准
- •Right-sided heart failure without left-sided failure
- •Current chronic use (within 4 weeks of registry entry) of any PAP therapy (e.g., CPAP, APAP, or bi-level) or contraindicated for PAP therapy
- •Sustained systolic blood pressure <80 mmHg at baseline
- •Complex congenital heart disease
- •Constrictive pericarditis
- •Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
- •Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry
- •Definite clinically evident acute myocardial infarction within 3 months of registry entry
- •Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
- •Moderate or greater valvular heart disease as the primary reason for heart failure
- •In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate
- •Inability to comply with planned study procedures
结局指标
主要结局
Adherence (hours/night)
时间窗: 3 months
Demonstrate acceptable adherence to ASV therapy can be achieved in patients with moderate to severe SDB in a recently hospitalized population of Heart Failure patients with preserved ejection fraction (HFpEF).
次要结局
- Quality of Life Score -(3 months)