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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.
Full description
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.
Enrollment
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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
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
Primary purpose
Allocation
Interventional model
Masking
126 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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