Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients (ARIA-II)
|ClinicalTrials.gov Identifier: NCT00804349|
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Sleep Apnea Syndromes||Device: Autotitrating Positive Airway Pressure||Phase 4|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Apnea Rampant In Acute Decompensated Heart Failure II|
|Study Start Date :||October 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
No Intervention: Control
Patients will receive standard medical therapy for heart failure only and will not receive Autotitrating Positive Airway Pressure therapy.
Active Comparator: Autotitrating Positive Airway Pressure
Patients will receive Autotitrating Positive Airway Pressure therapy in addition to standard medical care for heart failure.
Device: Autotitrating Positive Airway Pressure
Patients will be treated with Autotitrating Positive Airway Pressure therapy
- Reduction in episodic oxygen desaturation [ Time Frame: Concurrent ]
- Readmission [ Time Frame: 30 days post discharge ]
- Length of stay [ Time Frame: Concurrent ]
- Visual Analog Scale of Shortness of Breath [ Time Frame: Concurrent ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804349
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Darshak Karia, MD||Albert Einstein Medical Center. Albert Einstein Healthcare Network|