The Ohio State University
Columbus, Ohio, 43212, United States
NCT Number: NCT00679549
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43212, United States
Target population:
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.
Enrollment:
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 [46].
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPAP therapy is provided as an inpatient.
Other names: CPAP Device
Time frame: at baseline and 3 days post randomization
Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) *100.
the measurement unit of LVEF is %.
Ohio State University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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