Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
Primary Purpose
Sleep Apnea, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
auto adjusting bi-level positive airway pressure device
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF
Eligibility Criteria
.Inclusion Criteria:
- Able to provide an informed consent
- Speaks English
- Older than 21
- Heart Failure
- Positive for OSA
Exclusion Criteria:
- CSA
- Already on CPAP
- Hemodynamic instability
- Acute respiratory failure
- Neurological defect
- Dialysis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Device
Control
Arm Description
Provided with an auto adjusting bi-level positive airway pressure device
No device
Outcomes
Primary Outcome Measures
Left Ventricular Ejection Fraction Improvement
Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00701038
Brief Title
Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
Official Title
The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rami Khayat
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Congestive heart failure affects 2.3 percent of the population (approximately 4,900,000) with an incidence of 10 per 1,000 of the population after the age of 65 (1). The admission rate for patients with heart failure is on the rise, so is the mortality associated with it and its national annual bill, now exceeding $21 billion (1). Obstructive Sleep Apnea (OSA) is present in 11-37 percent of patients with heart failure (2,3), and tends to increase in severity when the heart failure is less controlled (4, 5). Therefore, the actual prevalence of OSA in patients hospitalized with acute heart failure is likely higher. There is now evidence that treatment of OSA with nasal Continuous Positive Pressure (nCPAP) in outpatients with stable heart failure improves left ventricular ejection fraction, and quality of life (6), and confers a reduction in fatal and non-fatal cardiovascular events (7). However, there has not been any evaluation of the role of diagnosis and treatment of OSA in patients hospitalized with acute heart failure. This uncertainty about the true prevalence and role of OSA in exacerbations of heart failure, and the role of its treatment in the acute setting may explain why aggressive diagnostic and therapeutic strategy for OSA in patients admitted to the hospital with acute heart failure is not part of the standard clinical practice in acute care centers. Given the rising admission rate, and mortality associated with heart failure, an evaluation of the role of OSA and its treatment in this patient population is highly significant.
Detailed Description
OSA is associated with large negative swings in the intrathoracic pressure, significant increase in the sympathetic nerve activity and repetitive surges in blood pressure, along with episodic hypoxia and hypercapnea (8, 9). These autonomic and respiratory changes may increase the cardiac muscle workload, cardiac dysrrhythmia, and exacerbate ischemia (10,11,12). Treatment with continuous positive airway pressure (CPAP) is the most successful therapeutic modality available for obstructive sleep apnea. It is still not clear whether establishing the diagnosis of OSA and initiating treatment with CPAP while still in the hospital carries any benefit in the management of patients with acute heart failure. This study will evaluate the effect of work up and treatment of OSA on the outcome of patients hospitalized with acute congestive heart failure (CHF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Heart Failure
Keywords
Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Experimental
Arm Description
Provided with an auto adjusting bi-level positive airway pressure device
Arm Title
Control
Arm Type
No Intervention
Arm Description
No device
Intervention Type
Device
Intervention Name(s)
auto adjusting bi-level positive airway pressure device
Other Intervention Name(s)
APAP, CPAP
Intervention Description
auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction Improvement
Description
Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.
Time Frame
baseline and again after three nights in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
.Inclusion Criteria:
Able to provide an informed consent
Speaks English
Older than 21
Heart Failure
Positive for OSA
Exclusion Criteria:
CSA
Already on CPAP
Hemodynamic instability
Acute respiratory failure
Neurological defect
Dialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rami N Khayat, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
Citation
Heart Disease and Stroke-Statistics, American Heart Association, 2005 update
Results Reference
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PubMed Identifier
9626176
Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
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