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    Clinical Trial Results:
    The effect of oxygen on exercise performance in chronic heart failure

    Summary
    EudraCT number
    		 2014-003380-38
    Trial protocol
    		 GB  
    Global end of trial date
    05 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2019
    First version publication date
    19 Jun 2019
    Other versions
    Summary report(s)
    		 Publication extract

    Trial information

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    Trial identification
    Sponsor protocol code
    Oxyperform
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull and East Yorkshire Hospitals NHS Trust
    Sponsor organisation address
    Anlaby Road, Hull, United Kingdom, HU3 2JZ
    Public contact
    Professor Andrew Clark, Academic Cardiology department, A.L.Clark@hull.ac.uk
    Scientific contact
    Professor Andrew Clark, Academic Cardiology department, 675312 461775, A.L.Clark@hull.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does short-term oxygen affect exercise capacity in patients with chronic heart failure?
    Protection of trial subjects
    Patients will normally remain within the trial for 2 months from consent. Patient participation in the trial will be discontinued if: • the patient withdraws consent • the patient opts to discontinue participation • the patient is withdrawn from the trial by the treating physician or medical researcher All subjects may withdraw at any time from the study. For any subject withdrawing from the trial, permission will be sought to use the data collected to the point of withdrawing. If patients wish their entire data set to be withdrawn from the trial, they may notify the principal investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 Breathlessness is a prominent symptom in heart failure. The use of home oxygen has proven efficacy in conditions such as COPD with a number of meta-analyses confirming its role in improving symptoms of breathlessness. A number of studies have looked into the effect of oxygen therapy on breathlessness.
    Actual start date of recruitment
    25 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    8
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients are identified from heart failure clinics. After giving consent they will be randomized via computer generation to receive either (a) room air (21% oxygen) (b) 28% oxygen or (c) 40% oxygen delivered via venturi mask following baseline investigations. Patients will be blinded to the oxygen concentration being received.

    Pre-assignment
    Screening details
    		 Inclusion Criteria: • Over 18 and able and willing to give consent • Have symptomatic heart failure on medical therapy • Able to use ergometer safely • Impaired left ventricular systolic function (at least “moderate” on echocardiography or ejection fraction <40% by any technique)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Only the members of the research team administering the oxygen will be aware of the concentration being investigated.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Room air
    Arm description
    		 No oxygen concentrator mask used.
    Arm type
    		 dummy oxygen concentrator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 28% o2
    Arm description
    		 Venturi mask used to generate an o2 concentration of 28%.
    Arm type
    		 venturi oxygen concentrator

    Investigational medicinal product name
    Venturi mask
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Buccal use
    Dosage and administration details
    It was necessary to put something here due to the shortcoming of the database.

    Arm title
    		 40% o2
    Arm description
    		 Venturi mask used to deliver an 02 concentration of 40%
    Arm type
    		 venturi oxygen concentrator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Room air 28% o2 40% o2
    Started
    11
    10
    10
    Completed
    11
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 7 7
        From 65-84 years
    		 24 24
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 24 24

    End points

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    End points reporting groups
    Reporting group title
    Room air
    Reporting group description
    		 No oxygen concentrator mask used.

    Reporting group title
    28% o2
    Reporting group description
    		 Venturi mask used to generate an o2 concentration of 28%.

    Reporting group title
    40% o2
    Reporting group description
    		 Venturi mask used to deliver an 02 concentration of 40%

    Primary: Exercise capacity

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    End point title
    		 Exercise capacity
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks (3 exercise tests)
    End point values
    		 Room air 28% o2 40% o2
    Number of subjects analysed
    11
    10
    10
    Units: VO2
        number (not applicable)
    11
    10
    10
    Statistical analysis title
    		 t-test
    Comparison groups
    Room air v 28% o2 v 40% o2
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 30 days post final exercise test.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    non serious AE
    Reporting group description
    		 -

    Serious adverse events
    		 non serious AE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 non serious AE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Musculoskeletal and connective tissue disorders
    Muscle strain
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26891754
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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