Condition category
Circulatory System
Date applied
05/06/2008
Date assigned
14/07/2008
Last edited
24/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Clark

ORCID ID

Contact details

Academic Cardiology
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom

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 measures

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

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

http://www.hull.ac.uk

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26393373

Publication citations

Additional files

Editorial Notes