Congestive heart failure Circulatory System Heart failure
Conditions
Interventions
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
Sponsors
University Health Network (Toronto) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined death-heart transplantation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Canada
Outcome results
None listed