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8110 Gatehouse Road, Falls Church, VA 22042

PEP ASV: Patients with Heart Failure with Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04133350

Background Information

This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in heart failure 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.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Mitchell Psotka, MD, PhD

Eligibility Information

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:
   a. Dyspnea at rest or with minimal exertion AND
   b. Treatment with at least one dose of IV diuretic or ultrafiltration AND
   c. 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

Ineligibility Information

  1. 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
  2. Right-sided heart failure without left-sided failure
  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