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Trial registered on ANZCTR
Registration number
ACTRN12610000556044
Ethics application status
Not yet submitted
Date submitted
25/06/2010
Date registered
9/07/2010
Date last updated
9/07/2010
Type of registration
Prospectively registered
Titles & IDs
Public title
The effects of Posture and Continuous Positive Airway Pressure (CPAP) on lung function in patients recovering from an acute exacerbation of heart failure
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Scientific title
In patients who have been admitted with worsening of their heart failure, does continuous positive airway pressure compared to oxygen result in an improvement in lung function?
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Secondary ID [1]
252102
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
257656
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Condition category
Condition code
Cardiovascular
257833
257833
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0
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Other cardiovascular diseases
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Respiratory
257834
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
10 minutes of continuous positive airway pressure at 10cm H2O pressure via nasal or full face mask in the sitting position
Followed by
10 minutes of continuous positive airway pressure at 10cm H2O pressure via nasal or full face mask in the supine position
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Intervention code [1]
256727
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Treatment: Devices
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Comparator / control treatment
10 minutes of oxygen at 2 lpm via nasal prongs in the sitting position
Followed by
10 minutes of oxygen at 2 lpm via nasal prongs in the supine position
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Control group
Active
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Outcomes
Primary outcome [1]
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Lung reactance and compliance as measured by the forced oscillation technique
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Assessment method [1]
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Timepoint [1]
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Daily during admission from time of randomisation and on day 30 post discharge.
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Primary outcome [2]
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Change in respiratory function tests (as a composite end point) including: forced expiratory time and vital capacity via spirometry, static lung volumes via body plethysmography and inert gas washout, gas transfer via the diffusing capacity of the lung for carbon monoxide (DLCO) method and respiratory muscle strength via maximal inspiratory and expiratory mouth pressures.
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Assessment method [2]
258694
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Timepoint [2]
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At days 2-4 of admission and then on discharge and on day 30 post discharge.
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Primary outcome [3]
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Lung heterogeneity via the nitrogen multi-breath washout technique
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Assessment method [3]
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Timepoint [3]
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At days 2-4 of admission and then on discharge and on day 30 post discharge.
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Secondary outcome [1]
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Change in clinical parameters (oxygen saturation and heart rate via pulse oximetry, respiratory rate clinically, blood pressure via automatic sphygmomanometer)
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Assessment method [1]
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Timepoint [1]
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Daily during admission from time of randomisation and on day 30 post discharge.
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Secondary outcome [2]
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change in BORG dyspnoea score
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Assessment method [2]
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Timepoint [2]
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Daily during admission from time of randomisation and on day 30 post discharge.
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Eligibility
Key inclusion criteria
Patients admitted to The Alfred with the diagnosis of an exacerbation of cardiac failure
Previous diagnosis of heart failure based on echocardiography
Stable clinical status: Respiratory Rate<35, oxygen saturation via pulse oximetry (SpO2) > 84% on room air, systolic blood pressure >90mmHg, clinically well perfused and able to talk sentences
Co-operative, able to give consent
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnancy
History of chronic lung disease requiring long term (>4 weeks) treatment
Severe renal (requiring dialysis) or neurological disease
Recent myocardial infarction (< 6 weeks)
Require intravenous inotropes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be enrolled into trial on day of admission. Randomisation will occur following enrollment and subjects allocated from an opaque envelope.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will involve drawing labelled cards from an opaque envelope. half the cards will be labelled CPAP and the other half will be labelled oxygen.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Royal Australian College of Physicians
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Address [1]
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145 Macquarie Street
Sydney, NSW, 2000
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Matthew Naughton
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Address
Head, General Respiratory and Sleep Medicine
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Kirk Kee
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Address [1]
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Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
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Country [1]
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
259233
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The Alfred Ethics Committee
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Ethics committee address [1]
259233
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The Alfred
PO Box 315
Prahran, Vic, 3181
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Ethics committee country [1]
259233
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Australia
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Date submitted for ethics approval [1]
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21/06/2010
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Approval date [1]
259233
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Ethics approval number [1]
259233
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1/10/0193
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Summary
Brief summary
This study aims to evaluate the effects of CPAP compared to oxygen on lung function in subjects as they recover from an episode of worsening heart failure. Subjects will be recruited on admission and have serial testing of their lung function early in their admission, just prior to discharge and 30 days following discharge. The effects of posture on lung function will also be evaluated.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirk Kee
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Address
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Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
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Country
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Australia
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Phone
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+61 3 9076 3770
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Kirk Kee
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Address
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Respiratory and Sleep Fellow
Department of Allergy, Immunology and Respiratory Medicine
The Alfred
PO Box 315
Prahran, Vic, 3181
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Country
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Australia
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Phone
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+61 3 9076 3770
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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