PMID- 26393373 OWN - NLM STAT- MEDLINE DCOM- 20160610 LR - 20210109 IS - 2046-4924 (Electronic) IS - 1366-5278 (Print) IS - 1366-5278 (Linking) VI - 19 IP - 75 DP - 2015 Sep TI - 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. PG - 1-120 LID - 10.3310/hta19750 [doi] AB - 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. OBJECTIVES: 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. DESIGN: 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. SETTING: Heart failure outpatient clinics in hospital or the community, in a range of urban and rural settings. PARTICIPANTS: 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. INTERVENTIONS: Patients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy. MAIN OUTCOME MEASURES: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60260702. FUNDING: 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. FAU - Clark, Andrew L AU - Clark AL AD - Hull York Medical School, Castle Hill Hospital, Cottingham, UK. FAU - Johnson, Miriam AU - Johnson M AD - Hull York Medical School, University of Hull, Hull, UK. FAU - Fairhurst, Caroline AU - Fairhurst C AD - Department of Health Sciences, York Trials Unit, University of York, York, UK. FAU - Torgerson, David AU - Torgerson D AD - Department of Health Sciences, York Trials Unit, University of York, York, UK. FAU - Cockayne, Sarah AU - Cockayne S AD - Department of Health Sciences, York Trials Unit, University of York, York, UK. FAU - Rodgers, Sara AU - Rodgers S AD - Department of Health Sciences, York Trials Unit, University of York, York, UK. FAU - Griffin, Susan AU - Griffin S AD - Centre for Health Economics, University of York, York, UK. FAU - Allgar, Victoria AU - Allgar V AD - Hull York Medical School, University of York, York, UK. FAU - Jones, Lesley AU - Jones L AD - School of Social Sciences, University of Hull, Hull, UK. FAU - Nabb, Samantha AU - Nabb S AD - Department of Sport, Health and Exercise Science, University of Hull, Hull, UK. FAU - Harvey, Ian AU - Harvey I AD - Department of Academic Cardiology, Castle Hill Hospital, Cottingham, UK. FAU - Squire, Iain AU - Squire I AD - Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK. FAU - Murphy, Jerry AU - Murphy J AD - Department of Cardiology, Darlington Memorial Hospital, Darlington, UK. FAU - Greenstone, Michael AU - Greenstone M AD - Medical Chest Unit, Castle Hill Hospital, Cottingham, UK. LA - eng GR - 06/80/01/DH_/Department of Health/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Health Technol Assess JT - Health technology assessment (Winchester, England) JID - 9706284 SB - IM MH - Aged MH - Aged, 80 and over MH - Chronic Disease MH - Cost-Benefit Analysis MH - Female MH - Heart Failure/*therapy MH - *Home Care Services MH - Humans MH - Linear Models MH - Male MH - Middle Aged MH - Outcome Assessment, Health Care MH - Oxygen Inhalation Therapy/*methods MH - *Quality of Life MH - Severity of Illness Index MH - *Standard of Care MH - Surveys and Questionnaires PMC - PMC4781070 EDAT- 2015/09/24 06:00 MHDA- 2016/06/11 06:00 PMCR- 2016/03/07 CRDT- 2015/09/23 06:00 PHST- 2015/09/23 06:00 [entrez] PHST- 2015/09/24 06:00 [pubmed] PHST- 2016/06/11 06:00 [medline] PHST- 2016/03/07 00:00 [pmc-release] AID - 10.3310/hta19750 [doi] PST - ppublish SO - Health Technol Assess. 2015 Sep;19(75):1-120. doi: 10.3310/hta19750.