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ISRCTN
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ISRCTN24943566
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ClinicalTrials.gov identifier
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Public title
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Auto-titrating continuous positive airway pressure in patients with chronic heart failure and obstructive sleep apnoea
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Scientific title
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Acronym
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N/A
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Serial number at source
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PG/02/131/14612
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Study hypothesis
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Auto-titrating Continuous Positive Airway Pressure (CPAP) improves subjective and objective measures of Chronic Heart Failure (CHF) severity in patients with CHF and Obstructive Sleep Apnoea (OSA).
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Lay summary
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Ethics approval
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The trial was approved by the Lothian Regional Ethics Committee (ref: LREC/2002/4/25) in 2002.
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Study design
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Randomised double-blind placebo-controlled crossover trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic heart failure and obstructive sleep apnoea
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Participants - inclusion criteria
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1. Stable symptomatic CHF (Left Ventricular Ejection Fraction [LVEF] less than 45%)
2. On optimal medical therapy with obstructive sleep apnoea (Apnea-Hypopnea Index [AHI] more than or equal to 15)
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Participants - exclusion criteria
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1. Acute coronary syndrome less than 3/12
2. Primary valvular heart disease
3. Sustained ventricular arrhythmias
4. Stroke with residual neurological deficit
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Anticipated start date
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01/07/2002
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Anticipated end date
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01/04/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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30
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Interventions
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Auto-titrating CPAP versus sham CPAP.
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Primary outcome measure(s)
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Changes in peak maximal oxygen uptake (VO2) and six-minute walk distance.
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Secondary outcome measure(s)
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Changes in:
1. LVEF
2. Minute ventilation versus carbon dioxide production (VE/VCO2) slope
3. Plasma neurohormonal makers
4. Quality of life
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Sources of funding
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British Heart Foundation (UK) (ref: PG/02/131/14612, PG/02/078/14122)
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Trial website
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Publications
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Results in:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17470670
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Contact name
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Prof
David
Newby
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Address
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Centre for Cardiovascular Science
Chancellor's Building
49 Little France Crescent
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City/town
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Edinburgh
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Zip/Postcode
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EH16 4SB
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Country
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United Kingdom
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Sponsor
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University of Edinburgh (UK)
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Address
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Old College
South Bridge
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City/town
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Edinburgh
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Zip/Postcode
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EH8 9YL
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Country
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United Kingdom
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Email
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communications.office@ed.ac.uk
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Sponsor website:
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http://www.ed.ac.uk/
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Date applied
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23/04/2006
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Last edited
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22/05/2007
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Date ISRCTN assigned
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20/11/2006
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