TY - JOUR
T1 - Nocturnal Oxygen Therapy for Central Sleep Apnea in Patients with Heart Failure; A Multisite, Double-Blind, Sham-controlled Randomized Clinical Trial (LOFT-HF)
AU - Redline, Susan
AU - Li, Dongdong
AU - Javaheri, Shahrokh
AU - Patel, Sanjay R.
AU - Parthasarathy, Sairam
AU - Fang, James C.
AU - Brown, Lee K.
AU - Dunlap, Mark
AU - Safwan Badr, M.
AU - Shah, Neomi
AU - Chi, Luqi
AU - Majid, Ruckshanda
AU - Teodorescu, Mihaela
AU - Stewart, Garrick
AU - Hsich, Eileen
AU - Polonsky, Tamar
AU - Vader, Justin
AU - Johnson, Maryl R.
AU - Auckley, Dennis
AU - Yaggi, Henry Klar
AU - Kao, Andrew
AU - Azarbarzin, Ali
AU - Alex, Raichel
AU - Rueschman, Michael
AU - Wolfe, Lisa
AU - Gottlieb, Daniel J.
AU - Sands, Scott A.
AU - Zee, Phyllis C.
AU - Mehra, Reena
AU - Mokhlesi, Babak
AU - Khayat, Rami
AU - Lewis, Eldrin F.
AU - Abraham, William T.
AU - Wang, Rui
N1 - Publisher Copyright:
© 2025 by the American Thoracic Society..
PY - 2025/12
Y1 - 2025/12
N2 - Rationale: There are insufficient data to inform the management of central sleep apnea (CSA) in patients with heart failure with reduced ejection fraction (HFrEF). Nocturnal oxygen therapy (NOT) has been postulated to benefit CSA patients with HFrEF but has not been rigorously studied. Objectives: To compare NOT with sham NOT (control) in heart failure (HF) patients receiving guideline-based HF therapy on the composite outcome of first occurrence of either mortality due to any cause, a lifesaving cardiovascular intervention, or an unplanned hospitalization for worsening HF, together with other secondary outcomes. Methods: A multisite, double-blind, sham-controlled randomized clinical trial was conducted from September 2019 to December 2021, when the study was terminated prematurely because of slow enrollment. Cox proportional-hazards regression models were used to analyze time-to-event outcomes. Results: Ninety-eight participants (mean left ventricular ejection fraction, 27.869.6%; mean central apnea–hypopnea index, 30.6618.2 events/h) were randomized and followed for an average of 10.866.3 months. A total of 22 events met the criteria for the primary composite endpoint. The hazard ratio comparing the NOT group with the control group according to time to first event, adjusted for the stratification factor (hospitalization for HF in the past 12 mo and/or elevated outpatient brain natriuretic peptide or Nterminal pro–B-type natriuretic peptide concentration) was 1.46 (95% confidence interval, 0.65–3.29). No group differences in changes in patient-reported outcomes (HF-specific quality of life [Kansas City Cardiomyopathy Questionnaire], sleep disturbance and sleep-related impairment [Patient-reported OutcomesMeasurement Information System], generic health [EQ-5D], ormood [Patient Health Questionnaire-8]) were observed at 6 months. Polysomnography showed improved indices of sleep-disordered breathing (apnea–hypopnea index, central apnea–hypopnea index, and time at oxygen saturation,90%) with oxygen compared with room air. Conclusions: Although NOT improves CSA and overnight oxygenation, this prematurely terminated study does not provide support for the clinical effectiveness of NOT in patients with CSA and HFrEF.
AB - Rationale: There are insufficient data to inform the management of central sleep apnea (CSA) in patients with heart failure with reduced ejection fraction (HFrEF). Nocturnal oxygen therapy (NOT) has been postulated to benefit CSA patients with HFrEF but has not been rigorously studied. Objectives: To compare NOT with sham NOT (control) in heart failure (HF) patients receiving guideline-based HF therapy on the composite outcome of first occurrence of either mortality due to any cause, a lifesaving cardiovascular intervention, or an unplanned hospitalization for worsening HF, together with other secondary outcomes. Methods: A multisite, double-blind, sham-controlled randomized clinical trial was conducted from September 2019 to December 2021, when the study was terminated prematurely because of slow enrollment. Cox proportional-hazards regression models were used to analyze time-to-event outcomes. Results: Ninety-eight participants (mean left ventricular ejection fraction, 27.869.6%; mean central apnea–hypopnea index, 30.6618.2 events/h) were randomized and followed for an average of 10.866.3 months. A total of 22 events met the criteria for the primary composite endpoint. The hazard ratio comparing the NOT group with the control group according to time to first event, adjusted for the stratification factor (hospitalization for HF in the past 12 mo and/or elevated outpatient brain natriuretic peptide or Nterminal pro–B-type natriuretic peptide concentration) was 1.46 (95% confidence interval, 0.65–3.29). No group differences in changes in patient-reported outcomes (HF-specific quality of life [Kansas City Cardiomyopathy Questionnaire], sleep disturbance and sleep-related impairment [Patient-reported OutcomesMeasurement Information System], generic health [EQ-5D], ormood [Patient Health Questionnaire-8]) were observed at 6 months. Polysomnography showed improved indices of sleep-disordered breathing (apnea–hypopnea index, central apnea–hypopnea index, and time at oxygen saturation,90%) with oxygen compared with room air. Conclusions: Although NOT improves CSA and overnight oxygenation, this prematurely terminated study does not provide support for the clinical effectiveness of NOT in patients with CSA and HFrEF.
UR - https://www.scopus.com/pages/publications/105027467408
UR - https://www.scopus.com/pages/publications/105027467408#tab=citedBy
U2 - 10.1513/AnnalsATS.202504-409OC
DO - 10.1513/AnnalsATS.202504-409OC
M3 - Article
C2 - 40929650
AN - SCOPUS:105027467408
SN - 2329-6933
VL - 22
SP - 1951
EP - 1960
JO - Annals of the American Thoracic Society
JF - Annals of the American Thoracic Society
IS - 12
ER -