cardiovascular improvements with mv asv therapy in heart failure

Conditions: Acute Decompensated Heart Failure; Sleep Disordered Breathing

Summary: the aim of the study is to compare the effects of mv targeted asv in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated hf. the study will also assess changes in functional parameters, biomarkers, quality of life (qol), and sleep.

this study is a randomized, unblinded, multi-center trial with parallel group design, with subjects randomized to either control (optimized medical therapy for chronic heart failure) or active treatment (optimized medical therapy plus use of mv-targeted asv) in a 1:1 ratio.

Eligibility criteria:
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

Keywords: heart failure congestive heart failure acute decompensated heart failure chronic heart failure left-sided heart failure heart failure decompensation sleep apnea sleep disordered breathing central sleep apnea obstructive sleep apnea cheyne-stokes respiration