Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000103268
Ethics application status
Approved
Date submitted
7/05/2008
Date registered
13/02/2009
Date last updated
13/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oxygen to Relieve Dyspnoea in Non-hypoxaemic Patients with End-stage Heart Failure
Scientific title
Oxygen therapy in heart failure to relieve dyspnoea and prevent hospitalisation
Universal Trial Number (UTN)
Trial acronym
OXYGEN-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 3121 0
Condition category
Condition code
Cardiovascular 3284 3284 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2867 0
Treatment: Drugs
Comparator / control treatment
Heart Failure Dyspnoea Action Plan alone (Control 1), Heart Failure Dyspnoea Action Plan plus air Control 2.
Heart Failure Dyspnoea Action Plan including strategies for symptom management and when to contact health professionals will be provided to participants in Control 1 and Control 2. Participants in Control 2 will be instructed to use air (21% oxygen) administered via nasal cannulae at 2L overnight 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 in Control 1 and Control 2 arms
Control group
Active

Outcomes
Primary outcome [1] 4172 0
All cause hospitalisation
Timepoint [1] 4172 0
6 weeks, 3 months, 6 months
Secondary outcome [1] 7040 0
Quality of life (QOL) using Minnesota Living with Heart Failure Questionnaire
Timepoint [1] 7040 0
6 weeks, 3 months, 6 months
Secondary outcome [2] 7041 0
Dyspnoea using Visual Analogue Scale and Breathlessness Scale
Timepoint [2] 7041 0
6 weeks, 3 months, 6 months
Secondary outcome [3] 7042 0
Physical functioning using New York Heart Association Functional Class, Australian Modified Karnofsky and Six Minute Walk Test
Timepoint [3] 7042 0
6 weeks, 3 months, 6 months
Secondary outcome [4] 7043 0
Costs including direct and indirect healthcare costs.
Costs related to service delivery will be calculated during the study and expressed as the cost/patient/month of follow-up. The cost of applying the intervention will include: (i) infrastructure costs for the intervention; (ii) community-based costs based on 2007/2008 Medicare schedules, diagnostic tests and costs related to hospitalisation and community based care (iii) gas (oxygen and air) medication usage according to 2007/2008 Pharmaceutical Benefits Schedule and (iv) costs incurred directly by the patient and their family eg unsubsidised help and in a subset of intervention and control group in-depth interview and questionnaire of carers to obtain direct and indirect costs.
The incremental costs per QALY gained
as well as other natural outcomes will be calculated. The scoring algorithms for the EQ-5D and the SF-12 will be used to convert patient scores into utility weights to calculate QALYs.
Timepoint [4] 7043 0
6 weeks, 3 months, 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be stratified according to their lowest recorded oxygen levels during a modified sleep study. -
Strata 1 – Sa02 <85
Strata 2 – Sa02 86-90
Strata 3 – Sa02 91-95
Strata 4 – Sa02 95-100
The randomisation form will be sent electronically via the Care Search Data Management System who will notify study sites of allocation and notify gas supplier. Study personnel will be blinded from gas allocation arms
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur according to a pre-specified schedule unknown to the researchers. Patients will be stratified according to their lowest recorded oxygen levels during a modified sleep study. -
Strata 1 – Sa02 <85
Strata 2 – Sa02 86-90
Strata 3 – Sa02 91-95
Strata 4 – Sa02 95-100
The randomisation form will be sent electronically via the Care Search Data Management System who will notify study sites of allocation and notify gas supplier. Study personnel will be blinded from gas allocation arms. The sequence generation will be generated electronically by permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
285
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 829 0
2008
Recruitment postcode(s) [2] 830 0
2145
Recruitment postcode(s) [3] 831 0
2170

Funding & Sponsors
Funding source category [1] 3364 0
Government body
Name [1] 3364 0
National Health & Medical Research Council
Country [1] 3364 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Centre for Cardiovascular and Chronic Care
39 Regent Street
CHIPPENDALE NSW 2008
Country
Australia
Secondary sponsor category [1] 3011 0
Hospital
Name [1] 3011 0
St Vincents Hospital
Address [1] 3011 0
Victoria Street
Darlinghurst
NSW 2010
Country [1] 3011 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5390 0
Curtin University of Technology
Ethics committee address [1] 5390 0
Ethics committee country [1] 5390 0
Australia
Date submitted for ethics approval [1] 5390 0
Approval date [1] 5390 0
07/03/2008
Ethics approval number [1] 5390 0
HR08/2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28574 0
Address 28574 0
Country 28574 0
Phone 28574 0
Fax 28574 0
Email 28574 0
Contact person for public queries
Name 11731 0
Professor Patricia Davidson
Address 11731 0
Centre for Cardiovascular and Chronic Care
Curtin University of Technology
39 Regent Street
CHIPPENDALE NSW 2008
Country 11731 0
Australia
Phone 11731 0
+ 61 2 83997831
Fax 11731 0
+ 61 2 83997834
Email 11731 0
[email protected]
Contact person for scientific queries
Name 2659 0
Professor Patricia Davidson
Address 2659 0
Centre for Cardiovascular and Chronic Care
Curtin University of Technology
39 Regent Street
CHIPPENDALE NSW 2008
Country 2659 0
Australia
Phone 2659 0
+ 61 2 83997831
Fax 2659 0
+ 61 2 83997834
Email 2659 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe Relationship Between Two Performance Scales: New York Heart Association Classification and Karnofsky Performance Status Scale2013https://doi.org/10.1016/j.jpainsymman.2013.05.006
N.B. These documents automatically identified may not have been verified by the study sponsor.