Principal Investigator: James Fang
Keywords: Central sleep apnea , Heart failure Department: Cardiovascular Medicine
IRB Number: 00122519 Co Investigator: Boaz  Markewitz
Specialty: Cardiology, Pulmonary
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Brittany Penn

Brief Summary

1. Compare the effect of standard Medical Management (MM)/sham NOXT vs NOXT on a composite primary endpoint of hospital readmission and mortality.
2. Compare the effect of MM/sham NOXT vs. NOXT on secondary endpoints including patient-reported outcomes (disease-specific and generic quality of life); exercise capacity; disease-specific causes of re-hospitalization and death; and cardiovascular events.
3. To conduct subgroup analyses to identify whether patients who have improved AHI with NOXT have better outcomes than the group treated with NOXT who have a high residual AHI, and to identify predictors of favorable long term responses to NOXT, including baseline level of hypoxemia, AHI, circulatory time, loop gain, and change in AHI with NOXT.

Inclusion Criteria

Age ≥ 21 years • History of chronic, stable HFrEF with a 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) and a central AHI ≥ 10/h or OAI > 20% of total AHI

• New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months (to enrich the overall study population for mortal/morbid events, at least 30% of the sample will be recruited with high-risk markers including hospitalization for HF in the last 12 months and/or an elevated outpatient BNP [≥ 150 pg/ml] or NTproBNP level [≥ 600 pg/ml])

• Treatment with stable, optimized 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 (reasons for intolerance to GDMT must be documented)

• In the investigator’s opinion, willing and able to comply with all study requirements

• Able to fully understand study information and sign an IRB-approved informed consent (including HIPAA authorization in the U.S.

Exclusion Criteria

• Current positive airway pressure use or diagnosis of OSA

• Oxygen saturation < 90% at rest during the day • Chronic daytime or nighttime use of supplemental oxygen

• Nocturnal oxygen saturation < 88% for > 5 minutes unaccompanied by apneas or hypopneas

• 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 COPD with FEV1 < 50%

• Body mass index (BMI) > 35 kg/m2

• 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) HF requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or endof-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