Patients With Heart Failure and Sleep Apnea
Conditions
Interventions
Active Comparator: Standard therapy for HF + ASV Subjects will receive treatment with Adaptive Servo Ventilation in addition to optimal standard therapy for heart failure conforming to national guid
Sponsors
Toronto Rehabilitation Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: American Heart Association Stage B-D Heart failure due to ischemic, idiopathic or hypertensive causes, present for at least 3 months 1.Left Ventricular Ejection Fraction less than 45 percent 2.Optimal medical therapy for heart failure 3.No change in active cardiac medications for 2 weeks prior to randomization, beta-blockers must be started 3 months prior to randomization 4.Sleep apnea with an AHI more than 15. Subjects with obstructive sleep apnea must also have an Epworth Sleepiness Scale score of less than 10 and no or mild daytime sleepiness 5.Written informed consent
Exclusion criteria
Exclusion criteria: Heart failure due to primary valvular heart disease 1.Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease 2.Hypertrophic obstructive or restrictive or post partum cardiomyopathy 3.Exercise capacity limited by class IV angina pectoris 4.Acute MI, cardiac surgery, PCI, AICD, or CRT within 3 months of randomization 5.Active myocarditis 6.Planned AICD or CRT 7.Presence of a left-ventricular assist device 8.Transplanted heart or expected to receive a transplanted heart within the next 6 months 9.Pregnancy 10.Current use of ASV or CPAP or treated with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications) 11.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 12.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) 13.Any contraindication to ASV therapy as detailed in the device provider manual
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to death from any cause Number of cardiovascular hospitalizations per year of follow-up Number of days alive not hospitalized 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 LV function will be assessed by echocardiography at 6 months post randomization Changes in plasma BNP levels Changes in plasma NT-proBNP levels will be assessed at baseline and at 6 months post randomization Cardiac resynchronization therapy or defibrillator implantations 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. Changes in 6 minute walk test distance Percentage of patients with changes in stages of heart failure and functional class Changes in apnea/hypopnea index Changes in Quality of life assessments | — |
Countries
Japan,North America,South America,Europe
Contacts
Public ContactTakatoshi Kasai
Juntendo Univ Dep Cardiology
Outcome results
None listed