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 |
| Protocol serial number | PG/02/131/14612 |
| Sponsor | University of Edinburgh (UK) |
| Funder | British Heart Foundation (UK) (ref: PG/02/131/14612, PG/02/078/14122) |
- 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 of protocol
Not provided at time of registration
Contact information
Prof David Newby
Scientific
Scientific
Centre for Cardiovascular Science
Chancellor's Building
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Auto-titrating continuous positive airway pressure in patients with chronic heart failure and obstructive sleep apnoea |
| Study objectives | 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. |
| Health condition(s) or problem(s) studied | Chronic heart failure and obstructive sleep apnoea |
| Intervention | Auto-titrating CPAP versus sham CPAP. |
| Intervention type | Other |
| Primary outcome measure(s) |
Changes in peak maximal oxygen uptake (VO2) and six-minute walk distance. |
| Key secondary outcome measure(s) |
Changes in: |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Total final enrolment | 26 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Centre for Cardiovascular Science
Edinburgh
EH16 4SB
United Kingdom
EH16 4SB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
