Multicentre trial of continuous Positive Airway Pressure for chronic therapy of heart failure

Completed

Conditions: Congestive heart failure
Circulatory System
Heart failure

Registration Number: ISRCTN25258560

Lead Sponsor: niversity Health Network (Toronto) (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 408

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined death-heart transplantation rate

Secondary Outcome Measures

Name	Time	Method
1. Changes in resting LVEF<br>2. Left ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVESV)<br>3. Distance walked on a six minute walk test<br>4. New York Heart Association (NYHA) functional class<br>5. Quality of life<br>6. Sleep quality<br>7. Frequency of apnoeas and hypopnoeas<br>8. Mean and minimal saturation of oxygen (SaO2) from baseline<br>9. Number of admissions and total days spent in hospital over the entire trial period