Multicentre trial of continuous Positive Airway Pressure for chronic therapy of heart failure
| ISRCTN | ISRCTN25258560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25258560 |
| Secondary identifying numbers | UCT-14909 |
- Submission date
- 17/06/2005
- Registration date
- 17/06/2005
- Last edited
- 14/04/2010
- 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
Dr T Douglas Bradley
Scientific
Scientific
Toronto General Hospital-UHN
EC 6-248
200 Elizabeth Street
Toronto, Ontario
M5G 2C4
Canada
| Phone | +1 416 340 4719 |
|---|---|
| douglas.bradley@utoronto.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CANPAP |
| Study objectives | To test the effect of continuous positive airway pressure (CPAP) on the combined rate of death and cardiac transplantation in congestive heart failure (CHF) patients with central sleep apnoea (CSA) |
| Ethics approval(s) | The research ethics board of each institution approved the protocol: 1. Canada: University of Calgary, University of Alberta, University of Western Ontario, McGill University, Laval University, University of Toronto (site A: Toronto General Hospital of the University Health Network, site B: St. Michael's Hospital), University of British Columbia, University of Manitoba 2. Germany: University of Regensburg |
| Health condition(s) or problem(s) studied | Congestive heart failure |
| Intervention | Control group: Standard drug therapy for CHF Experimental group: CPAP in addition to standard drug therapy Both groups will be closely followed for an average of approximately 2.5 years. Assessments at one, three and six months, two years and end of trial. |
| Intervention type | Other |
| Primary outcome measure | Combined death-heart transplantation rate |
| Secondary outcome measures | 1. Changes in resting LVEF 2. Left ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVESV) 3. Distance walked on a six minute walk test 4. New York Heart Association (NYHA) functional class 5. Quality of life 6. Sleep quality 7. Frequency of apnoeas and hypopnoeas 8. Mean and minimal saturation of oxygen (SaO2) from baseline 9. Number of admissions and total days spent in hospital over the entire trial period |
| Overall study start date | 01/12/1998 |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 408 |
| Key inclusion criteria | 1. Male and females between the age of 18 and 79 with history of at least one clinical episode of CHF due to ischaemic heart failure 2. Left ventricular (LV) systolic dysfunction as evidenced by a left ventricular ejection fraction (LVEF) at rest determined by equilibrium radionuclide angiography of less than 40% while on optimal drug therapy at the time of recruitment 3. New York Heart Association (NYHA) functional class two to four 4. Stable condition and stable optimal cardiac medications for at least one month prior to entry 5. Presence of central sleep apnoea defined as more than or equal to 15 apnoeas and hypopneas per hour of sleep of which more than 50% must be central in nature 6. Written informed consent |
| Key exclusion criteria | 1. History of unstable angina, cardiac surgery and/or documented myocardial infarction less than three months prior to entry into the study 2. Acceptance for cardiac transplantation 3. Sleep apnea which is predominantly (i.e. more than or equal to 50%) obstructive in nature 4. Concurrent disease that would markedly limit life expectancy (e.g. lung cancer) 5. Pregnancy |
| Date of first enrolment | 01/12/1998 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto General Hospital-UHN
Toronto, Ontario
M5G 2C4
Canada
M5G 2C4
Canada
Sponsor information
University Health Network (Toronto) (Canada)
University/education
University/education
200 Elizabeth Street
Toronto, Ontario
M5G 2C4
Canada
| Phone | +1 416 340 4719 |
|---|---|
| douglas.bradley@utoronto.ca | |
| Website | http://www.uhn.ca |
"ROR" |
https://ror.org/042xt5161 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-14909)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/06/2001 | Yes | No | |
| Results article | results | 10/11/2005 | Yes | No | |
| Results article | results | 26/06/2007 | Yes | No | |
| Results article | results | 01/01/2009 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No |
