Study ID: LOFT-HF
The impact of low-flow nocturnal oxygen therapy on hospital admissions and mortality in patients with heart failure and central sleep apnea
This randomized trial seeks to determine if nocturnal oxygen therapy (NOXT), a non-invasive administration of oxygen during sleep, can help patients who have been diagnosed with heart failure and central sleep apnea.
Patients are randomized into one of two study arms:
- Arm 1 receives active NOXT
- Arm 2 receives placebo NOXT (the machine uses room air instead of oxygen)
The purpose of this trial is to evaluate the long-term effects of nocturnal oxygen therapy on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction, already receiving optimal guideline-directed medical therapy, and who have central sleep apnea.
The primary outcome being measured is first occurrence of mortality due to any cause or an unplanned hospitalization for worsening heart failure or a life-saving cardiovascular intervention.
Eligible participants are those with the following:
- A history of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction ≤ 45% within the year prior to enrollment
- Central sleep apnea as defined using an apnea-hypopnea index > 15/h with ≥ 50% central events
- NYHA Class III or IV, or NYHA Class II with ≥ 1 hospitalization for heart failure in the past 24 months
- Other significant inclusion and exclusion criteria apply
- Must have been diagnosed with heart failure and sleep apnea
- Must be age 21 or older
- Must be willing and able to sleep will being administered NOXT