Cardiovascular Improvements With MV ASV Therapy in Heart Failure

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ResMed
• Collaborator: ResMed Foundation

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