title: Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure.
abstract: BACKGROUND
  Home oxygen therapy (HOT) is commonly used for patients with severe chronic heart failure (CHF) who have intractable breathlessness. There is no trial evidence to support its use.
  
  
  OBJECTIVE
  To detect whether or not there was a quality-of-life benefit from HOT given as long-term oxygen therapy (LTOT) for at least 15 hours per day in the home, including overnight hours, compared with best medical therapy (BMT) in patients with severely symptomatic CHF.
  
  
  METHODS
  A pragmatic, two-arm, randomised controlled trial recruiting patients with severe CHF. It included a linked qualitative substudy to assess the views of patients using home oxygen, and a free-standing substudy to assess the haemodynamic effects of acute oxygen administration.
  
  
  METHODS
  Heart failure outpatient clinics in hospital or the community, in a range of urban and rural settings.
  
  
  METHODS
  Patients had to have heart failure from any aetiology, New York Heart Association (NYHA) class III/IV symptoms, at least moderate left ventricular systolic dysfunction, and be receiving maximally tolerated medical management. Patients were excluded if they had had a cardiac resynchronisation therapy device implanted within the past 3 months, chronic obstructive pulmonary disease fulfilling the criteria for LTOT or malignant disease that would impair survival or were using a device or medication that would impede their ability to use LTOT.
  
  
  METHODS
  Patients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy.
  
  
  METHODS
  The primary end point was quality of life as measured by the Minnesota Living with Heart Failure (MLwHF) questionnaire score at 6 months. Secondary outcomes included assessing the effect of LTOT on patient symptoms and disease severity, and assessing its acceptability to patients and carers.
  
  
  RESULTS
  Between April 2012 and February 2014, 114 patients were randomised to receive either LTOT or BMT. The mean age was 72.3 years [standard deviation (SD) 11.3 years] and 70% were male. Ischaemic heart disease was the cause of heart failure in 84%; 95% were in NYHA class III; the mean left ventricular ejection fraction was 27.8%; and the median N-terminal pro-B-type natriuretic hormone was 2203 ng/l. The primary analysis used a covariance pattern mixed model which included patients only if they provided data for all baseline covariates adjusted for in the model and outcome data for at least one post-randomisation time point (n = 102: intervention, n = 51; control, n = 51). There was no difference in the MLwHF questionnaire score at 6 months between the two arms [at baseline the mean score was 54.0 (SD 18.4) for LTOT and 54.0 (SD 17.9) for BMT; at 6 months the mean score was 48.1 (SD 18.5) for LTOT and 49.0 (SD 20.2) for BMT; adjusted mean difference -0.10, 95% confidence interval (CI) -6.88 to 6.69; p = 0.98]. At 3 months, the adjusted mean MLwHF questionnaire score was lower in the LTOT group (-5.47, 95% CI -10.54 to -0.41; p = 0.03) and breathlessness scores improved, although the effect did not persist to 6 months. There was no effect of LTOT on any secondary measure. There was a greater number of deaths in the BMT arm (n = 12 vs. n = 6). Adherence was poor, with only 11% of patients reporting using the oxygen as prescribed.
  
  
  CONCLUSIONS
  Although the study was significantly underpowered, HOT prescribed for 15 hours per day and subsequently used for a mean of 5.4 hours per day has no impact on quality of life as measured by the MLwHF questionnaire score at 6 months. Suggestions for future research include (1) a trial of patients with severe heart failure randomised to have emergency oxygen supply in the house, supplied by cylinders rather than an oxygen concentrator, powered to detect a reduction in admissions to hospital, and (2) a study of bed-bound patients with heart failure who are in the last few weeks of life, powered to detect changes in symptom severity.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN60260702.
  
  
  BACKGROUND
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 75. See the NIHR Journals Library website for further project information.
authors.affiliation: Hull York Medical School, Castle Hill Hospital, Cottingham, UK.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Clark
authors.affiliation: Hull York Medical School, University of Hull, Hull, UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Johnson
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Fairhurst
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Cockayne
authors.affiliation: Department of Health Sciences, York Trials Unit, University of York, York, UK.
authors.forename: Sara
authors.initials: S
authors.lastname: Rodgers
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Griffin
authors.affiliation: Hull York Medical School, University of York, York, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Allgar
authors.affiliation: School of Social Sciences, University of Hull, Hull, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Jones
authors.affiliation: Department of Sport, Health and Exercise Science, University of Hull, Hull, UK.
authors.forename: Samantha
authors.initials: S
authors.lastname: Nabb
authors.affiliation: Department of Academic Cardiology, Castle Hill Hospital, Cottingham, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Harvey
authors.affiliation: Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
authors.forename: Iain
authors.initials: I
authors.lastname: Squire
authors.affiliation: Department of Cardiology, Darlington Memorial Hospital, Darlington, UK.
authors.forename: Jerry
authors.initials: J
authors.lastname: Murphy
authors.affiliation: Medical Chest Unit, Castle Hill Hospital, Cottingham, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Greenstone
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D003362:Cost-Benefit Analysis; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006699:Home Care Services; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010102:Oxygen Inhalation Therapy / Q000379:methods*; D011788:Quality of Life; D012720:Severity of Illness Index; D059039:Standard of Care; D011795:Surveys and Questionnaires