ISRCTN67500535Completed未知
Multi-centre, randomized study to assess the effects of adaptive servo ventilation on survival and frequency of cardiovascular hospital admissions in patients with heart failure and sleep apnea: the ADVENT-HF trial
niversity Health Network/Toronto Rehabilitation Institute (Canada)0 sites731 target enrollmentStarted: April 30, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 731
Study Overview
Brief Summary
2017 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29065956 Polysomnography results in participants with Cheyne-Stokes respiration with central sleep apnea (CSR-CSA) (added 10/04/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38142697/ (added 27/12/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female 18 years or older
- •2. Documented American Heart Association Stages B, C and D HF due to ischemic, idiopathic or hypertensive causes for at least 3 months
- •3. Left ventricular ejection fraction (LVEF) = 45%, as determined by echocardiography at screening
- •4. On optimal medical therapy conforming to contemporary national or American Heart Association guidelines, as determined by the patient's primary cardiologist
- •5. No changes in active cardiac medication during 2 weeks prior to randomization; if patient is on a beta-blocker, beta-blocker therapy must have been started at least 3 months prior to randomization
- •6. Sleep apnea with an Apnea/Hypopnea Index (AHI) = 15, which will be divided into Obstructive Sleep Apnea (OSA) (greater than or equal to 50% events obstructive), or Central Sleep Apnea (CSA) (> 50% of events central in nature). For patients with OSA, an Epworth Sleepiness Scale (ESS) score of = 10 and no or mild daytime sleepiness (by the International Classification of Sleep Disorders: occasionally falling asleep during passive situations, is considered mild and not pathological). For patients with CSA, no ESS or subjective sleepiness criteria will be used, since there is very little evidence that CSA is associated with hypersomnolence, or that treating CSA reduces sleepiness.
- •7. Written informed consent
Exclusion Criteria
- •1. HF due to primary valvular heart disease
- •2. Presence of moderate to severe mitral insufficiency due to intrinsic mitral valve disease. If mitral insufficiency is secondary to the cardiomyopathic state, patients can be included
- •3. Hypertrophic obstructive or restrictive or post partum cardiomyopathy
- •4. Exercise capacity limited by class IV angina pectoris
- •5. Acute Myocardial Infarction (MI), cardiac surgery, Percutaneous Coronary Intervention (PCI), Automatic Implantable Cardioverter Defibrillator (AICD)-if implanted for pacing function or secondary prevention , or Cardiac Resynchronization Therapy (CRT) within 3 months of randomization; only a 2-week waiting period before randomization is required if the AICD is implanted for primary prevention
- •6. Active myocarditis
- •7. Planned AICD or CRT
- •8. Presence of a left-ventricular assist device (LVAD)
- •9. Transplanted heart or expected to receive a transplanted heart within the next 6 months
- •10. Pregnancy
- •11. Current use of ASV, BiPAP, CPAP or mandibular advancement device for treatment of sleep apnea or treatment with any investigational therapy during the last 4 weeks (including approved therapies being used in unapproved indications)
- •12. A clinical history that would interfere with the objectives of this study or that would in the investigator's opinion reduce 5 year life expectancy
- •13. 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)
- •14. Any contraindication to ASV therapy as detailed in the device provider manual
Investigators
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