Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Study Overview
=================
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).

Official Title
-----------------
The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Conditions
-----------------
Sleep Apnea, Heart Failure

Intervention / Treatment
-----------------
* Device: auto adjusting bi-level positive airway pressure device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Provided with an auto adjusting bi-level positive airway pressure device | Device: auto adjusting bi-level positive airway pressure device<br>* auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.<br>* Other names: CPAP;|
| No Intervention: Control<br>No device | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and again after three nights in hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF