Status:
COMPLETED
The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
Lead Sponsor:
Ohio State University
Conditions:
Heart Failure
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 standa...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2014
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00679549
Start Date
March 1 2008
End Date
March 22 2014
Last Update
May 14 2019
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43212