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

Completed · Not applicable

Conditions studied: Heart Failure, Obstructive Sleep Apnea, Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT00679549

Run by

Ohio State University

People needed

154

Starts

2008-03-01

Expected to finish

2014-03-22

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously unrecognized OSA with an Apnea Hypopnea Index (AHI) > 15 events per hour on the attended in-hospital sleep study. Patients with apnea index of less than 5 events / hour are excluded (see design consideration for rationale)
• Projected length of stay 3 days or more on the morning following the cardio-respiratory sleep study
• Ongoing or planned targeted treatment for heart failure including one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy

You may not qualify if…

• Patients who are already diagnosed with OSA
• Patients with Central Sleep Apnea
• Patients with diastolic only heart failure
• Cardiogenic shock and hemodynamic instability with MAP less than 55 mmHg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic Balloon Pump. Inotropic agents will not constitute an exclusion criterion. Patients will be eligible once off vasopressors.
• Acute respiratory failure or insufficiency defined by P/F (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 50%
• Overt neurological deficit
• Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal
• Patients scheduled for procedures that will interfere with post randomization measurement: This includes scheduled coronary bypass surgery, or expected left ventricular assist device placement.
• Patients who arrived from a long-term care facility or expected to be discharged to one; and patients who have very poor functional outcome precluding ability to use the CPAP device independently.
• Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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