Status:
COMPLETED
Oxygen Versus PAP for Sleep Apnea in Heart Failure
Lead Sponsor:
VA Office of Research and Development
Conditions:
Heart Failure
Sleep Apnea Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The ...
Detailed Description
Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chron...
Eligibility Criteria
Inclusion
- Veteran receiving care within the Veterans Health Administration healthcare system
- Age 18 years
- Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
- LVEF \<45%
- No change in active cardiac medications for 4 weeks prior to randomization
- Ability to provide informed consent
- Moderate to severe central or mixed central and obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) 15 events per hour, with a central AHI \>5 events/hour
Exclusion
- Hospitalization for acute decompensated HF within previous 30 days
- Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
- Presence of a left ventricular assist device
- History of heart transplantation
- Poorly controlled hypertension (\>170/\>110)
- Poorly controlled diabetes (HbA1c \> 9.0)
- Severe renal failure with estimated glomerular filtration rate \<30 ml/min
- Prior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records
- Severe chronic insomnia, with reported usual sleep duration \<4 hours
- Severe daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year, and deemed a safety risk by study physician
- Awake resting oxyhemoglobin saturation \<89%
- Pregnancy
- Smoking by subject or other person in the subject's bedroom, or other open flame in bedroom
- Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy
Key Trial Info
Start Date :
June 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01807897
Start Date
June 23 2014
End Date
June 30 2020
Last Update
January 25 2023
Active Locations (2)
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1
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
2
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130