None listed
Conditions
Brief summary
Heart failure (HF) is one of the most common causes of hospitalisation, particularly among the elderly. Breathlessness is a common reason for patients presenting to hospital. Although the use of oxygen in acute HF with hypoxaemia is well established, there is no evidence to support or refute the use of oxygen in chronic HF. The OXYGEN-HF Study seeks to test the hypothesis that oxygen administered in conjunction with a dyspnoea action plan will decrease rates of hospitalisation compared with air and a dyspnoea action plan and a dyspnoea action plan alone in patients with New York Heart Association Class III-IV heart failure.
Interventions
Heart Failure Dyspnoea Action Plan including strategies for symptom management and when to contact health professionals will be provided to participants at baseline and reinforced at 6 weeks, 3 months, 6 months. Participants will be instructed to use oxygen administered via nasal cannulae at 2-3 Litres per minute (approximately 28% oxygen) overnight while sleeping (approximated at 6-8 hours) and when short of breath over a period of 6 months. Symptom management instructions will be given in writ
Heart Failure Dyspnoea Action Plan including strategies for symptom management and when to contact health professionals will be provided to participants at baseline and reinforced at 6 weeks, 3 months, 6 months. Participants will be instructed to use oxygen administered via nasal cannulae at 2-3 Litres per minute (approximately 28% oxygen) overnight while sleeping (approximated at 6-8 hours) and when short of breath over a period of 6 months. Symptom management instructions will be given in written and verbal form at baseline and each of the outcome assessment points at 6 weeks, 3 months and 6 months.
Sponsors
Curtin University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Heart failure of either systolic or diastolic aetiology classified by New York Heart Association Class III-IV Receiving optimal therapy or documented intolerance/trial (as outlined by the Chronic Heart failure guidelines developed by the Cardiac Society of Australia and new Zealand and the National Heart Foundation History of two or more presentations to hospital within the previous six months with heart failure as the primary diagnosis.
Exclusion criteria
Unable or unwilling to give informed consent Not investigated for reversible causes of heart failure (HF) Undergoing current treatment for sleep disorder breathing Significant cognitive impairment and/or dementia PaCO2 > 45mmHg on room air Eligible for domiciliary oxygen under current funding guidelines Resident in residential aged care facility Current smokers
Outcome results
None listed