Status:
COMPLETED
CPAP Therapy in Patients With Heart Failure and Obstructive Sleep Apnea.
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Conditions:
Heart Failure
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Heart failure affects approximately 5-6 million North Americans and is increasing in prevalence. Sleep-related disorders, such as obstructive sleep apnea (OSA) often coexist (11-37% incidence) with he...
Detailed Description
OSA and heart failure (HF) are states of increased afterload, metabolic demand and sympathetic nervous system(SNS) activation. In patients with OSA and HF, CPAP initially may reduce LV stroke volume(S...
Eligibility Criteria
Inclusion
- systolic LV dysfunction (LVEF\<40%; by echocardiography, radionuclide or contrast ventriculography)
- symptoms of HF: NYHA Class II to III
- stable condition with optimally tolerated medical therapy, unchanged for \> 4 weeks
- Obstructive sleep apnea (OSA) diagnosed on nocturnal polysomnogram with an apnea/hypopnea index (AHI) \>15 events/hr and a predominantly obstructive pattern(more than 80% of events being obstructive in nature)OR
- no OSA: defined as AHI\<5 (control subjects) will be matched with the OSA group for gender, age + 5 years, ejection fraction (EF) +5%, drug therapy and etiology of HF (ischemic or non-ischemic)
- willingness to receive CPAP therapy
- informed consent
Exclusion
- unstable angina or recent myocardial infarction (MI) (\<4 weeks prior)
- severe valvular dysfunction
- requirement for revascularization
- a permanent pacemaker
- atrial fibrillation
- significant ventricular arrhythmia or sinus node dysfunction
- life expectancy less than 1 year due to other co-morbidity
- significant restrictive and obstructive lung disease
- concomitant treatment or use of: tricyclic antidepressants, cocaine or drugs which may alter catecholamine uptake; or hypnotic, benzodiazepine, selective serotonin reuptake inhibitors(SSRI), neuroleptic, narcotic or other medications which may alter sleep or sleep-disordered breathing
- central sleep apnea
- other primary sleep disorder (i.e. periodic limb movement with arousal \>5 events/hr, narcolepsy, rapid eye movement (REM) behaviour disorder)
- requiring supplemental oxygen therapy at night
- debilitating daytime somnolence (indicating clear-cut indication for CPAP therapy)
- a previous cardiac transplant
- a large transmural scar defined on previous perfusion imaging(severe resting perfusion defect (\<50% uptake) occupying \>25% of the LV)148-150
- age \< 18 years
- pregnant or breast-feeding
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00756366
Start Date
July 1 2005
End Date
December 1 2011
Last Update
May 30 2018
Active Locations (1)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7