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
• Results First Posted: March 9, 2020
• Last Update Posted: March 9, 2020
• Sponsor: Albert Einstein Healthcare Network
• Collaborator: Nexan Inc
• Information provided by (Responsible Party): Albert Einstein Healthcare Network

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure; Sleep Apnea Syndromes	Device: Autotitrating Positive Airway Pressure	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Apnea Rampant In Acute Decompensated Heart Failure II
• Study Start Date: October 2008
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Reduction in Episodic Oxygen Desaturation [ Time Frame: Concurrent ]
   0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Secondary Outcome Measures :

1. Readmission [ Time Frame: 30 days post discharge ]
   0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
2. Length of Stay [ Time Frame: Concurrent ]
   0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.
3. Visual Analog Scale of Shortness of Breath [ Time Frame: Concurrent ]
   0 participants analyzed. Study closed; PI no longer at the institution. Efforts to have the PI add the required information have been unsuccessful. No study data are available.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States, 19141

Sponsors and Collaborators

Albert Einstein Healthcare Network

Nexan Inc

Investigators

• Principal Investigator: Darshak Karia, MD; Albert Einstein Medical Center. Albert Einstein Healthcare Network

More Information

• Responsible Party: Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT00804349
• Other Study ID Numbers: HN-3025
• First Posted: December 8, 2008
• Results First Posted: March 9, 2020
• Last Update Posted: March 9, 2020
• Last Verified: February 2013

Keywords provided by Albert Einstein Healthcare Network:

Heart Decompensation; Heart Failure, Congestive; Heart Failure, Left-Sided; Heart Failure, Right-Sided; Apnea, Sleep; Sleep Apnea, Mixed Central and Obstructive; Sleep Hypopnea; Sleep-Disordered Breathing

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Heart Failure; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases