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Inability to Recruit
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| Name | Class |
|---|---|
| Inova Fairfax Hospital | OTHER |
| Heart and Diabetes Center North Rhine-Westphalia | OTHER |
| CLEMENS HOSPITAL | UNKNOWN |
| Resmed Inc |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Patient Engagement | Experimental | All patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Patient Engagement | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (hours/night) | 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Score - | 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 | 3 months |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States | ||
| INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital) |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| UNKNOWN |
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| Falls Church |
| Virginia |
| 22042 |
| United States |
| Herz- und Diabeteszentrum, Nordrhein-Westfalen | Bad Oeynhausen | Ruhr-Universität Bochum | Germany |
| Ludgerus Clinic, Department of Cardiology, Clemens Hospital | Münster | Germany |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |