The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).
- Heart Failure
- Central Sleep Apnea
- Eligible Ages
- Over 21 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Aged ≥ 21 years at the date of consent.
- History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 45% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
- Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas).
- New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months.
- Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization.
- In the investigator's opinion, willing and able to comply with all study requirements
- Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent
- Current positive airway pressure use of diagnosis of Obstructive Sleep Apnea (OSA).
- Oxygen saturation < 90% at rest during the day.
- Oxygen saturation < 88% for > 5 continuous minutes during sleep unaccompanied by respiratory events.
- Chronic daytime or nighttime use of supplemental oxygen.
- Current smoker or bed partner that smokes in the bedroom.
- Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
- Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
- Transient ischemic attack or stroke within the previous 3 months.
- Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
- Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial
- Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
- End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
- Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
- Life expectancy < 1 year for diseases unrelated to chronic HF.
- Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
Nocturnal Oxygen Therapy
|Active nocturnal oxygen therapy||
Sham Nocturnal Oxygen Therapy
|Sham nocturnal oxygen therapy (room air)||
- Brigham and Women's Hospital
Study ContactEmily Kaplan