Cardiovascular Improvements With MV ASV Therapy in Heart Failure

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