Condition category
Circulatory System
Date applied
17/06/2005
Date assigned
17/06/2005
Last edited
14/04/2010
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

Dr T Douglas Bradley

ORCID ID

Contact details

Toronto General Hospital-UHN
EC 6-248
200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4719
douglas.bradley@utoronto.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UCT-14909

Study information

Scientific title

Acronym

CANPAP

Study hypothesis

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/1998

Overall trial end date

31/05/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

408

Participant 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

Recruitment start date

01/12/1998

Recruitment end date

31/05/2004

Locations

Countries of recruitment

Canada

Trial participating centre

Toronto General Hospital-UHN
Toronto, Ontario
M5G 2C4
Canada

Sponsor information

Organisation

University Health Network (Toronto) (Canada)

Sponsor details

200 Elizabeth Street
Toronto
Ontario
M5G 2C4
Canada
+1 416 340 4719
douglas.bradley@utoronto.ca

Sponsor type

University/education

Website

http://www.uhn.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-14909)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2001 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11420579
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16282177
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17562959
4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19189783
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/20190331

Publication citations

  1. Protocol

    Bradley TD, Logan AG, Floras JS, , Rationale and design of the Canadian Continuous Positive Airway Pressure Trial for Congestive Heart Failure patients with Central Sleep Apnea--CANPAP., Can J Cardiol, 2001, 17, 6, 677-684.

  2. Results

    Bradley TD, Logan AG, Kimoff RJ, Sériès F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Tomlinson G, Floras JS, , Continuous positive airway pressure for central sleep apnea and heart failure., N. Engl. J. Med., 2005, 353, 19, 2025-2033, doi: 10.1056/NEJMoa051001.

  3. Results

    Arzt M, Floras JS, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson K, Belenkie I, Pfeifer M, Fleetham J, Hanly P, Smilovitch M, Ryan C, Tomlinson G, Bradley TD, , Suppression of central sleep apnea by continuous positive airway pressure and transplant-free survival in heart failure: a post hoc analysis of the Canadian Continuous Positive Airway Pressure for Patients with Central Sleep Apnea and Heart Failure Trial (CANPAP)., Circulation, 2007, 115, 25, 3173-3180, doi: 10.1161/CIRCULATIONAHA.106.683482.

  4. Results

    Ruttanaumpawan P, Logan AG, Floras JS, Bradley TD, , Effect of continuous positive airway pressure on sleep structure in heart failure patients with central sleep apnea., Sleep, 2009, 32, 1, 91-98.

  5. Results

    Ryan CM, Floras JS, Logan AG, Kimoff RJ, Series F, Morrison D, Ferguson KA, Belenkie I, Pfeifer M, Fleetham J, Hanly PJ, Smilovitch M, Arzt M, Bradley TD, , Shift in sleep apnoea type in heart failure patients in the CANPAP trial., Eur. Respir. J., 2010, 35, 3, 592-597, doi: 10.1183/09031936.00070509.

Additional files

Editorial Notes