Heart Failure, Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, central sleep apnea, heart failure, congestive heart failure, adaptive servo ventilation, ASV
Brief summary
Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.
Interventions
BiPAP autoSV ADVANCED device worn nightly during sleep
Sponsors
Canadian Institutes of Health Research (CIHR)
Philips Respironics
Toronto Rehabilitation Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months * Left Ventricular Ejection Fraction ≤ 45 % * Optimal medical therapy for heart failure * No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization * Sleep apnea with an AHI ≥ 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of ≤ 10 and no or mild daytime sleepiness * Written informed consent
Exclusion criteria
* Heart failure due to primary valvular heart disease * Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease * Hypertrophic obstructive or restrictive or post partum cardiomyopathy * Exercise capacity limited by class IV angina pectoris * Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization * Active myocarditis * Planned AICD or CRT * Presence of a left-ventricular assist device * Transplanted heart or expected to receive a transplanted heart within the next 6 months * Pregnancy * Current use of ASV or CPAP or mandibular advancement device for treatment of sleep apnea or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications) * A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion preclude safe conclusion of the study * Any other medical, social, or geographical factor, which would make it unlikely that the patient will comply with the study procedures (e.g. alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or history of non-compliance) * Any contraindication to ASV therapy as detailed in the device provider manual
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time to the composite outcome of death or first CV hospital admission or new onset atrial fibrillation/flutter requiring anti-coagulation but not hospitalization or delivery of an appropriate shock from an ICD not resulting in hospitalization. | The expected study follow-up period is five years | The study will end once 540 primary endpoints have occurred. The maximum follow-up period for all randomized subjects is 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cardiovascular hospitalizations per year of follow-up | The minimum time of follow-up is expected to be 2 years. The maximum time of follow-up is expected to be 5 years | — |
| Number of days alive not hospitalized | Time from randomization to censoring (death, primary event or end of study) | The number of days the patient is hospitalized are subtracted from the total number of days in the study from randomization. This number will be compared between the 2 groups. |
| Changes in left ventricular function | 6 months from randomization | Changes in LV function will be assessed by echocardiography at baseline and at 6 months post randomization |
| Changes in plasma BNP levels | 6 months from randomization | Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization |
| Time to death from any cause | The expected study follow-up period is 5 years | The study will end once 540 primary endpoints have occurred. |
| Changes in 6 minute walk test distance | 6 months from randomization | Changes in the 6-minute walk distance between baseline and 6 months will be compared between the 2 groups |
| Percentage of patients with changes in stages of heart failure and functional class | Values obtained at study termination will be compared to those obtained at randomization | New York Heart Association classification and AHA/ACC Stages of Heart Failure will be assessed at each visit. |
| Changes in apnea/hypopnea index | 1 month from randomization | — |
| Changes in Quality of life assessments | Assessments made at baseline, 1, 6, 12 and every 6 months thereafter | Minnesota living with Heart Failure Questionnaire and Epworth Sleepiness Scale will be used. Scores will be compared between the 2 groups. |
| Cardiac resynchronization therapy or defibrillator implantations | Average number of days until first cardiac resynchronization or first defibrillator implantation | The average number of days from randomization to the first occurrence of CRT or defibrillator implantation will be calculated and compared between each treatment arm. |
Countries
Brazil, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States
Outcome results
None listed