Condition category
Circulatory System
Date applied
23/04/2006
Date assigned
20/11/2006
Last edited
22/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Newby

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PG/02/131/14612

Study information

Scientific title

Acronym

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

The trial was approved by the Lothian Regional Ethics Committee (ref: LREC/2002/4/25) in 2002.

Study design

Randomised double-blind placebo-controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic heart failure and obstructive sleep apnoea

Intervention

Auto-titrating CPAP versus sham CPAP.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2002

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30

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

United Kingdom

Trial participating centre

Centre for Cardiovascular Science
Edinburgh
EH16 4SB
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom
communications.office@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK) (ref: PG/02/131/14612, PG/02/078/14122)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17470670

Publication citations

  1. Results

    Smith LA, Vennelle M, Gardner RS, McDonagh TA, Denvir MA, Douglas NJ, Newby DE, Auto-titrating continuous positive airway pressure therapy in patients with chronic heart failure and obstructive sleep apnoea: a randomized placebo-controlled trial., Eur. Heart J., 2007, 28, 10, 1221-1227, doi: 10.1093/eurheartj/ehm131.

Additional files

Editorial Notes