Cardiovascular Improvements With MV ASV Therapy in Heart Failure

Inclusion Criteria:

- Patients 21 years or older

- Patients with prior clinical diagnosis of heart failure (HFrEF or HFpEF), or de novo
diagnosis of HFpEF indicated by a local BNP≥300 pg/mL or NT pro-BNP≥1200 pg/mL on
admission without systolic blood pressure >180 mmHg or atrial fibrillation, or
diagnosis of HFrEF indicated by documented evidence of prescribed beta-blockers and
ACE-inhibitors or ARBs for at least 4 weeks prior to admission

- Hospital admission for acute decompensated HF as determined by:

- Dyspnea at rest or with minimal exertion

- AND At least two of the following signs and symptoms:

- Orthopnea

- Pulmonary rales beyond basilar

- Chest congestion on x-ray

- BNP≥300pg/mL or NT pro-BNP≥1200pg/mL

- Pulmonary capillary wedge pressure (PCWP) ≥25mmHg during current hospitalization

- Presented to hospital or clinic at least 24 hours prior to consent

- Patient stable enough to stop oxygen use for duration of polygraphy test or have
access to dual lumen cannula for polygraphy test

- Sleep disordered breathing (SDB) documented by polygraphy with an AHI≥15 events/hour

- Patient is able to fully understand study information and sign a consent form

Exclusion Criteria:

- Right-sided heart failure without left-sided heart failure

- Sustained systolic blood pressure <80 mmHg at baseline

- Acute coronary syndrome within 1 months of randomization

- Active myocarditis

- Complex congenital heart disease

- Constrictive pericarditis

- Non-cardiac pulmonary edema

- Clinical evidence of digoxin toxicity

- Need for mechanical hemodynamic support at time of randomization

- Oxygen saturation ≤85% at rest during the day or at start of nocturnal oximetry
recording or regular use of oxygen therapy (day or night)

- COPD exacerbation as the primary reason for hospital admission

- Current use (within 4 weeks of study entry) of any PAP-therapy (eg, fixed, bi-level,
or APAP)

- Life expectancy < 1 year for diseases unrelated to HF

- Transient ischemic attack (TIA) or Stroke within 3 months prior to randomization

- CABG procedure within 3 months prior to randomization, or planned to occur during
study period

- CRT implant within 3 months prior to randomization , or planned to occur during study
period

- VAD implant planned to occur during study period

- Heart transplant list Status 1a or 1b

- Status post-transplant or LVAD

- Prescribed inotrope therapy anticipated at discharge

- Chronic Dialysis

- Known amyloidosis, hypertrophic obstructive cardiomyopathy, arteriovenous fistulas

- Primary hemodynamically significant uncorrected valvular heart disease (obstructive or
regurgitant) with planned intervention within 6 months of randomization

- Pregnant, or planning to become pregnant

- Cannot tolerate ASV treatment during run-in

- Cannot perform 6MWT at baseline

- Occupation as a commercial driver or pilot and plan to be performing these activities
during the study period

- Inability to comply with planned study procedures

- Participation in pharmaceutical or treatment-related clinical study within 1 month of
study enrollment