Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
Heart Failure affects 5-6 million Americans and there are about 550 thousand new cases of
 heart failure every year. There are approximately 3 million hospital admission for acute
 decompensated heart failure with hospital readmission rate of 20% at 30 days and 50% at 60
 day, costing up to 20 billion dollars per year. In our previous study we have discovered that
 sleep disordered breathing is prevalent in 70% of patients with acute decompensated heart
 failure. We hypothesize that, detection and treatment of sleep disordered breathing in acute
 decompensated heart failure patients will reduce episodic hypoxic events during acute
 decompensation and may decrease hospital length of stay and reduce future readmissions.
Background:

 Heart failure (HF) affects 5 to 6 million Americans and is increasing in prevalence. There
 are about 550,000 new cases of heart failure every year and about 3 million admissions for
 acute decompensated heart failure every year. Despite advances in medical care, the hospital
 readmission rate is 20% at one month and 50% at six months. The total cost of heart failure
 on the health system is upwards of 35 billion dollars per year. About half of these resources
 are used during acute hospitalizations.

 An important limitation to the current approach to the management of HF is the focus on the
 awake patient. This approach underestimates the mechanisms that might contribute to the
 pathophysiology or progression of HF.

 Sleep disordered breathing (SDB) is very common in congestive heart failure. Recently, the
 adverse implications of SDB in patients with HF have been appreciated. Intermittent
 apnea-induced hypoxia, hypercapnia, surges in central sympathetic outflow and left
 ventricular afterload, daytime hypertension, and loss of vagal heart rate regulation are
 potent stimuli to myocyte necrosis and apoptosis, myocardial ischemia, arrhythmias, adverse
 cardiac remodeling, and the resulting accelerated disease progression in HF.

 This makes us believe that treatment of SDB during acute decompensated heart failure in
 addition to standard medical therapy (SMT) would be beneficial.

 Study Design:

 80 eligible patients admitted to Albert Einstein Medical Center with the diagnosis of Acutely
 Decompensated Heart Failure will be recruited for the study. Once patients have been
 identified, inclusion and exclusion criteria met, they will be consented to participate in
 the trial within 24 to 48 hours of admission to the hospital. After enrollment, the patient
 will be screened for SDB with NEXAN CPS system. The Sensor, a flexible data collection patch
 that adheres to the patient's chest, continuously records ECG, respiratory, and oximetry data
 and allows for future use and evaluation. Patients with SDB will be further randomized to SDB
 monitoring only and SDB monitoring plus Autotitratable Continuous Positive Airway Pressure
 (APAP) treatment arm. Patients in both arms will be treated with standard of care therapy for
 acute heart failure. There is a possibility that patients randomized to APAP therapy may
 refuse further treatment after the first night. These patients will be analyzed on the basis
 of intention to treat approach

 Once randomized, all patients will be fitted with the NEXAN Clear Path System and will
 continue to wear it until the time of discharge or 7 days. Those in the treatment group will
 be fitted with an Autotitratable Continuous Positive Airway Pressure device and will be
 continued on treatment until discharged or a maximum of 7 days.

 Follow-up of these patients will include a 15 day and 60 day phone call and a 30 day office
 visit. At the 30 day visit the patients will be asked to use the NEXAN sensor for that night,
 and return the equipment the next day. The patients that were determined to have
 sleep-disordered breathing will be referred for a full overnight polysomnography test.
Inclusion Criteria:

 -  Patients over the age of 18 and able to consent

 -  NYHA Class III/IV Symptoms

 -  Objective Evidence of Heart Failure

 -  Physical Exam consistent with Heart Failure

 -  BNP greater than 500

 -  Radiographic Evidence of Heart Failure

 -  SDB (AHI > 5/hour) on Nexan CPS

 -  Ability to tolerate appropriate medical therapy for Heart Failure

 -  Willingness to follow-up as an outpatient after discharge

 Exclusion Criteria:

 -  Patients with known Sleep-Disordered Breathing currently using CPAP or BiPAP

 -  Patients with known COPD

 -  Patients with known restrictive lung disease

 -  Patients with tracheostomy in place

 -  Acute MI/Acute Coronary Syndrome at time of hospitalization

 -  Cardiogenic Shock

 -  Troponin Leak greater than 0.08

 -  Patients with major multisystem disorders

 -  Expected survival less than 6 months

 -  End Stage Renal Disease on Dialysis

 -  Chronic Liver Disease

 -  Albumin level less than 3.

 -  Patients from Nursing homes