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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

Clark, Andrew L.; Johnson, Miriam; Fairhurst, Caroline; Torgerson, David; Cockayne, Sarah; Rodgers, Sara; Griffin, Susan; Allgar, Victoria; Jones, Lesley; Nabb, Samantha; Harvey, Ian; Squire, Iain; Murphy, Jerry; Greenstone, Michael

Authors

Andrew L. Clark

Caroline Fairhurst

David Torgerson

Sarah Cockayne

Sara Rodgers

Susan Griffin

Victoria Allgar

Lesley Jones

Samantha Nabb

Ian Harvey

Iain Squire

Jerry Murphy

Michael Greenstone



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.

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.

Journal Article Type Article
Publication Date Sep 1, 2015
Journal Health Technology Assessment
Print ISSN 1366-5278
Electronic ISSN 2046-4924
Publisher NIHR Journals Library
Peer Reviewed Peer Reviewed
Volume 19
Issue 75
Pages 1-120
APA6 Citation Clark, A. L., Johnson, M., Fairhurst, C., Torgerson, D., Cockayne, S., Rodgers, S., …Greenstone, M. (2015). 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. Health Technology Assessment, 19(75), 1-120. https://doi.org/10.3310/hta19750
DOI https://doi.org/10.3310/hta19750
Publisher URL https://www.journalslibrary.nihr.ac.uk/hta/hta19750/#/abstract
Copyright Statement © Queen’s Printer and Controller of HMSO 2015. This work was produced by Clark et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising.
Additional Information Contractual start date: 01-2010; Editorial review begun: 11-2014; Accepted for publication: 05-2015

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Copyright Statement
© Queen’s Printer and Controller of HMSO 2015. This work was produced by Clark et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising.





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