Heart Failure, Sleep Disorder; Breathing-Related
Conditions
Brief summary
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.
Interventions
BEHAVIORALActive Patient Engagement
The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.
Sponsors
Inova Fairfax Hospital
Heart and Diabetes Center North Rhine-Westphalia
CLEMENS HOSPITAL
Resmed Inc
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Dyspnea at rest or with minimal exertion AND 2. Treatment with at least one dose of IV diuretic or ultrafiltration AND 3. 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
Exclusion criteria
1. Right-sided heart failure without left-sided failure 2. 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 3. Sustained systolic blood pressure \<80 mmHg at baseline 4. Complex congenital heart disease 5. Constrictive pericarditis 6. 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) 7. Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry 8. Definite clinically evident acute myocardial infarction within 3 months of registry entry 9. Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas 10. Moderate or greater valvular heart disease as the primary reason for heart failure 11. In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate 12. Inability to comply with planned study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (hours/night) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score - | 3 months | Quality of life will be assessed using the KCCQ-12, a 12-item validated instrument that measures Quality of Life in heart failure patients on a scale of 0-100. Higher scores indicate higher Quality of Life |
Countries
Germany, United States
Outcome results
None listed