Auto-titrating continuous positive airway pressure in patients with chronic heart failure and obstructive sleep apnoea

ISRCTN	ISRCTN24943566
DOI	https://doi.org/10.1186/ISRCTN24943566
Secondary identifying numbers	PG/02/131/14612

Submission date: 23/04/2006
Registration date: 20/11/2006
Last edited: 14/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof David Newby
Scientific

Centre for Cardiovascular Science
Chancellor's Building
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom

Study information

Study design	Randomised double-blind placebo-controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Auto-titrating continuous positive airway pressure in patients with chronic heart failure and obstructive sleep apnoea
Study hypothesis	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).
Ethics approval(s)	The trial was approved by the Lothian Regional Ethics Committee (ref: LREC/2002/4/25) in 2002.
Condition	Chronic heart failure and obstructive sleep apnoea
Intervention	Auto-titrating CPAP versus sham CPAP.
Intervention type	Other
Primary outcome measure	Changes in peak maximal oxygen uptake (VO2) and six-minute walk distance.
Secondary outcome measures	Changes in: 1. LVEF 2. Minute ventilation versus carbon dioxide production (VE/VCO2) slope 3. Plasma neurohormonal makers 4. Quality of life
Overall study start date	01/07/2002
Overall study end date	01/04/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	30
Total final enrolment	26
Participant inclusion criteria	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)
Participant exclusion criteria	1. Acute coronary syndrome less than 3/12 2. Primary valvular heart disease 3. Sustained ventricular arrhythmias 4. Stroke with residual neurological deficit
Recruitment start date	01/07/2002
Recruitment end date	01/04/2005

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Centre for Cardiovascular Science

Edinburgh
EH16 4SB
United Kingdom

Sponsor information

University of Edinburgh (UK)
University/education

Old College
South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom

Email	communications.office@ed.ac.uk
Website	http://www.ed.ac.uk/
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Charity

British Heart Foundation (UK) (ref: PG/02/131/14612, PG/02/078/14122)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2007		Yes	No

Editorial Notes

14/11/2022: Total final enrolment added.