Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry) (PEP-ASV)
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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.
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).
Secondary Outcome Measures :
Quality of Life Score [ Time Frame: 3 months ]
The study will determine if acceptable adherence to this therapy can be achieved in this population using the AirCurve 10 device.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
1. Patients 18 years or older 2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) 3. 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 4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) 5. Patient is able to fully understand study information and sign informed consent
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
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