{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T10:27:08Z","timestamp":1792319228780,"version":"4.4.0"},"reference-count":99,"publisher":"National Institute for Health and Care Research","issue":"75","license":[{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["06\/80\/01"],"award-info":[{"award-number":["06\/80\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Heart failure outpatient clinics in hospital or the community, in a range of urban and rural settings.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>Patients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>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\u2009ng\/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 (<jats:italic>n<\/jats:italic>\u2009=\u2009102: intervention,<jats:italic>n<\/jats:italic>\u2009=\u200951; control,<jats:italic>n<\/jats:italic>\u2009=\u200951). 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 \u20130.10, 95% confidence interval (CI) \u20136.88 to 6.69;<jats:italic>p<\/jats:italic>\u2009=\u20090.98]. At 3 months, the adjusted mean MLwHF questionnaire score was lower in the LTOT group (\u20135.47, 95% CI \u201310.54 to \u20130.41;<jats:italic>p<\/jats:italic>\u2009=\u20090.03) 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 (<jats:italic>n<\/jats:italic>\u2009=\u200912 vs.<jats:italic>n<\/jats:italic>\u2009=\u20096). Adherence was poor, with only 11% of patients reporting using the oxygen as prescribed.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Conclusions<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN60260702.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the NIHR Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 19, No. 75. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta19750","type":"journal-article","created":{"date-parts":[[2015,9,23]],"date-time":"2015-09-23T14:23:05Z","timestamp":1443018185000},"page":"1-120","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":28,"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"],"prefix":"10.3310","volume":"19","clinical-trial-number":[{"clinical-trial-number":"isrctn60260702","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Andrew L","family":"Clark","sequence":"first","affiliation":[{"name":"Hull York Medical School, Castle Hill Hospital, Cottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Johnson","sequence":"additional","affiliation":[{"name":"Hull York Medical School, University of Hull, Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Fairhurst","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, York Trials Unit, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Torgerson","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, York Trials Unit, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Cockayne","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, York Trials Unit, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Rodgers","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, York Trials Unit, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Griffin","sequence":"additional","affiliation":[{"name":"Centre for Health Economics, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victoria","family":"Allgar","sequence":"additional","affiliation":[{"name":"Hull York Medical School, University of York, York, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lesley","family":"Jones","sequence":"additional","affiliation":[{"name":"School of Social Sciences, University of Hull, Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Nabb","sequence":"additional","affiliation":[{"name":"Department of Sport, Health and Exercise Science, University of Hull, Hull, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Harvey","sequence":"additional","affiliation":[{"name":"Department of Academic Cardiology, Castle Hill Hospital, Cottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iain","family":"Squire","sequence":"additional","affiliation":[{"name":"Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Murphy","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Darlington Memorial Hospital, Darlington, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Greenstone","sequence":"additional","affiliation":[{"name":"Medical Chest Unit, Castle Hill Hospital, Cottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2015,9]]},"reference":[{"key":"key20150922140744999_ref1-bib1","doi-asserted-by":"publisher","first-page":"421","DOI":"10.1053\/euhj.1998.1280","article-title":"Incidence and aetiology of heart failure; a population-based study","volume":"20","author":"Cowie","year":"1999","journal-title":"Eur Heart J"},{"key":"key20150922140744999_ref1-bib2","doi-asserted-by":"publisher","first-page":"606","DOI":"10.1161\/HHF.0b013e318291329a","article-title":"Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association","volume":"6","author":"Heidenreich","year":"2013","journal-title":"Circ Heart Fail"},{"key":"key20150922140744999_ref1-bib3","volume-title":"National Heart Failure Audit April 2012\u2013March 2013","author":"National Institute for Cardiovascular Outcomes Research","year":"2013"},{"key":"key20150922140744999_ref1-bib4","doi-asserted-by":"publisher","first-page":"1234","DOI":"10.1016\/S0735-1097(03)00948-3","article-title":"Delivering the cumulative benefits of triple therapy to improve outcomes in heart failure: too many cooks will spoil the broth","volume":"42","author":"Cleland","year":"2003","journal-title":"J Am Coll Cardiol"},{"key":"key20150922140744999_ref1-bib5","doi-asserted-by":"publisher","first-page":"907","DOI":"10.1001\/jama.1989.03430070055030","article-title":"Functional status and well-being of patients with chronic conditions. 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