Clinical Trial Results:
The effect of oxygen on exercise performance in chronic heart failure
Summary
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EudraCT number |
2014-003380-38 |
Trial protocol |
GB |
Global end of trial date |
05 Nov 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Jun 2019
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First version publication date |
19 Jun 2019
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Other versions |
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Summary report(s) |
Publication extract |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Oxyperform
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Hull and East Yorkshire Hospitals NHS Trust
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Sponsor organisation address |
Anlaby Road, Hull, United Kingdom, HU3 2JZ
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Public contact |
Professor Andrew Clark, Academic Cardiology department, A.L.Clark@hull.ac.uk
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Scientific contact |
Professor Andrew Clark, Academic Cardiology department, 675312 461775, A.L.Clark@hull.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Nov 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Does short-term oxygen affect exercise capacity in patients with chronic heart failure?
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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.
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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
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 31
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Worldwide total number of subjects |
31
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EEA total number of subjects |
31
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
8
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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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
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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
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pressurised inhalation
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Routes of administration |
Buccal use
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Dosage and administration details |
It was necessary to put something here due to the shortcoming of the database.
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Arm title
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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
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Room air
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Reporting group description |
No oxygen concentrator mask used. | ||
Reporting group title |
28% o2
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Reporting group description |
Venturi mask used to generate an o2 concentration of 28%. | ||
Reporting group title |
40% o2
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Reporting group description |
Venturi mask used to deliver an 02 concentration of 40% |
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End point title |
Exercise capacity | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
2 weeks (3 exercise tests)
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Statistical analysis title |
t-test | ||||||||||||||||
Comparison groups |
Room air v 28% o2 v 40% o2
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||||||
upper limit |
- | ||||||||||||||||
Variability estimate |
Standard error of the mean
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Adverse events information
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Timeframe for reporting adverse events |
Up to 30 days post final exercise test.
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Assessment type |
Systematic | ||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
non serious AE
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Reporting group description |
- | ||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0.05% | |||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/26891754 |