Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Nocturnal Oxygen Therapy
Active nocturnal oxygen therapy
  • Drug: Oxygen
    Active nocturnal oxygen concentrator
  • Other: Room Air
    Sham nocturnal oxygen concentrator (room air)
    Other names:
    • Sham Oxygen
Sham Comparator
Sham Nocturnal Oxygen Therapy
Sham nocturnal oxygen therapy (room air)
  • Other: Room Air
    Sham nocturnal oxygen concentrator (room air)
    Other names:
    • Sham Oxygen

Recruiting Locations

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Mary Rangel
713-500-6851
Mary.Rangel@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Emily Kaplan
617-278-0382
ekaplan1@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.