Cardiovascular Improvements With MV ASV Therapy in Heart Failure

Stopped early · Not applicable

Conditions studied: Acute Decompensated Heart Failure, Sleep Disordered Breathing

In brief

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.

Key facts

Study ID

NCT01953874

Run by

ResMed

People needed

126

Starts

2013-12-01

Expected to finish

2015-12-01

Last updated by the study team

2018-02-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Heart Center — Huntsville, Alabama, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• VA Medical Center — Denver, Colorado, United States
• Mercer University — Macon, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• St. Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Penn State Hershey — Hershey, Pennsylvania, United States
• Jefferson Heart Institute — Philadelphia, Pennsylvania, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Heart and Diabetes Center - North Rhine-Westphalia (HDZ-NRW) — Bad Oeynhausen, Germany

Full record on ClinicalTrials.gov

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