The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
This study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital.
Heart failure affects more than 2% of the US population and is the only cardiovascular disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which may shorten length of stay, improve functional status of discharged patient, and reduce rehospitalizations.
Obstructive Sleep Apnea
Heart Failure, Congestive
Device: CPAP Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure|
- EF Improvement [ Time Frame: 3 month ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- BNP, BUN, Creatine levels [ Time Frame: 3 month ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Provided CPAP as an inpatient
Device: CPAP Therapy
CPAP therapy is provided as an inpatient.
Other Name: CPAP Device
No Intervention: Control
No device provided
Patients admitted to the OSU Heart Hospital with ADHF routinely undergo a cardiorespiratory sleep study to identify OSA. Patients with ADHF who are newly diagnosed with OSA during the same hospital stay are eligible for this study.
Given the presence of significant previously unrecognized OSA in 62% of patients hospitalized with ADHF, we expect to need to screen 270 patient volunteers to recruit 170 patients with OSA.
Eligibility for randomization: The criteria for ADHF is admission diagnosis of heart failure; a chief complaint of dyspnea; and ejection fraction of 45% or less. Additionally, elevated left ventricular pressure as indicated by at least one sign and one symptom of volume overload (pedal edema, crackles, consistent chest X-ray, increased left ventricular end-diastolic diameter, or elevated BNP level) is required .
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679549
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43212|
|Principal Investigator:||Rami N Khayat, MD||Ohio State University|