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Sponsored by: |
Ohio State University |
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Information provided by: | Ohio State University |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention |
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Heart Failure Obstructive Sleep Apnea Heart Failure, Congestive |
Device: CPAP Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure |
Estimated Enrollment: | 170 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DEVICE: Experimental
Provided CPAP as an inpatient
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Device: CPAP Therapy
CPAP therapy is provided as an inpatient.
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Control: No Intervention
No device provided
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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].
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Ohio State University ( Dr . Rami Khayat ) |
Study ID Numbers: | 2008H0011 |
Study First Received: | May 15, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00679549 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart Failure Obstructive Sleep Apnea OSA |
CHF Sleep apnea CHD |
Signs and Symptoms Heart Failure Sleep Apnea Syndromes Heart Diseases Respiratory Tract Diseases Apnea |
Respiration Disorders Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Heart Failure Sleep Apnea Syndromes Heart Diseases Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Cardiovascular Diseases |