Clinical Trials Directory

Trials / Completed

CompletedNCT00679549

The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
154 (actual)
Sponsor
Ohio State University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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 \[46\].

Conditions

Interventions

TypeNameDescription
DEVICECPAP TherapyCPAP therapy is provided as an inpatient.

Timeline

Start date
2008-03-01
Primary completion
2014-03-22
Completion
2014-03-22
First posted
2008-05-19
Last updated
2019-05-14
Results posted
2019-05-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00679549. Inclusion in this directory is not an endorsement.