Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 06/80/01; Version 1
Study information
Scientific title
Does home oxygen therapy (HOT) in addition to standard care improve disease severity and symptoms in chronic heart failure?
Acronym
NEON
Study hypothesis
What is the role of home oxygen therapy (HOT) in the management of patients with chronic heart failure (CHF)? To address the current uncertainties in patients with New York Heart Association (NYHA) class III/IV chronic heart failure with regard to the place of oxygen therapy in their management. This is a feasibility study (Stage 1) conducted in preparation for the main (Stage 2) randomised controlled trial.
On 10/09/2009 the overall trial start and end dates were updated from 01/09/2008 and 01/12/2009 to 01/01/2010 and 31/12/2010, respectively.
On 05/07/2013 the overall trial end date was updated from 31/12/2010 to 01/01/2015.
Ethics approval
Northern and Yorkshire Research Ethics Committee, 24/08/2009, ref: 09/H0903/42
Study design
Prospective four-arm multicentre randomised feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Heart failure
Intervention
The participants will be randomised to receive HOT as nocturnal oxygen therapy (NOT) or long-term oxygen treatment (LTOT). Once randomised to one of the two modes of oxygen delivery, there will be a second randomisation to active oxygen therapy or sham (placebo) therapy. This stage of the study will be double-blind. The first and second randomisations will each be in 1:1 ratio.
Total duration of interventions: 3 months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To assess the feasibility of the proposed randomised control trial in the following regard:
1. Prevalence of hypoxaemia in patients with NYHA III/IV and optimal medical therapy. Assessment of arterial oxygenation by:
1.1. Arterial saturation by pulse oximetry at baseline and at the completion of the 6 minute walk test
1.2. Overnight oximetry using the Embletta® to record (i) nadir of oxygenation overnight (ii) proportion of night time spent with oxygen saturation below 95%
2. Recruitment and retention of study patients and their compliance with trial intervention. Criteria for proceeding to the larger RCT phase of the study:
2.1. Recruitment rate >= 3 patients per week per centre during the recruitment phase
2.2. Drop out rate (excluding deaths) of <= 15% at 3 months
2.3. Compliance >= 27%
Number of hours of oxygen used will be measured by concentrator meter and patient diaries.
3. The value of the intervention for a preliminary cost-effectiveness analysis: Minnesota Living with Heart Failure (MLwHF) quality of life questionnaire scores at baseline, 1 and 3 months.
4. To develop a cost-effectiveness model of HOT based on existing evidence (to asses the likely benefit of proceeding to the larger RCT phase of the study)
5. Expected value of perfect information (EVPI) associated with the data to be collected in the proposed trial, that is, whether the patient benefits from the improvement in treatment decisions possible with the additional information provided by the trial is worth the cost of undertaking a definitive clinical trial of this intervention. To use this to inform the design of the subsequent main trial.
Secondary outcome measures
1. To assess the effect of HOT delivered as NOT or LTOT on the following:
1.1. Symptoms (total duration of follow-up: 3 months):
a. Assessed using the results of standard biochemistry tests
b. 6 minute walk test
c. Prevalence of hypoxaemia results
d. Validated Borg score and Numerical Rating Scale (NRS) for breathlessness (average and worse over past 24 hours and current level)
d. Change in validated Karnofsky performance scale of physical activity
e. Epworth Sleepiness score to assess daytime somnolence
f. Co-morbidity measured by the Charlson co-morbidity index
1.2. Quality of life, as measured by MLWHF, Hospital Anxiety and Depression (HAD) (mood assessment) and EuroQoL questionnaires at baseline, 1 and 3 months
1.3. Disease severity in patients with CHF, as measured by the validated Borg score and NRS for breathlessness (average and worse over past 24 hours and current level). Total duration of follow-up: 3 months
2. To assess the cost-effectiveness of HOT (see 3 in Primary outcome measures)
3. To assess the acceptability to patients and carers of study intervention and placebo device (Patient diary at enrolment, 1 and 3 months)
4. To assess the acceptability of the placebo device to clinicians (through communications with the research teams)
Overall trial start date
01/01/2010
Overall trial end date
01/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, aged 18 years or over
2. Heart failure grade NYHA III/IV with left ventricular (LV) systolic dysfunction confirmed by echocardiography. The left ventricular ejection fraction must be less than 40% or graded as at least "moderately" impaired on visual inspection if an accurate ejection fraction cannot be calculated
3. Heart failure from any aetiology
4. Maximally tolerated medical management of their heart failure
5. Provided written informed consent and able to complete patient assessments
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
Patients who:
1. Are unable to provide informed consent
2. Are unable to complete patient related information on entry
3. Have chronic obstructive pulmonary disease (COPD) likely to fulfil criteria for long-term oxygen treatment (LTOT); forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <70% and FEV1 <40% predicted and hypoxia (pO2 <7.3 kPa or saturations <90%)
4. Have co-existing malignant disease if this would affect the study in the investigators' opinion
5. Patients with persistent basal pulmonary crackles found to have interstitial lung disease
6. Unwilling or unable to comply with safety regulations regarding oxygen use, particularly smoking
Recruitment start date
01/01/2010
Recruitment end date
01/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
Sponsor information
Organisation
University of Hull (UK)
Sponsor details
c/o Jonathan Cant
Venn Building
Cottingham Road
Hull
HU6 7RX
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26393373