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Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients (ARIA-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Nexan Inc
Information provided by (Responsible Party):
Albert Einstein Healthcare Network

Tracking Information
First Submitted Date  ICMJE December 5, 2008
First Posted Date  ICMJE December 8, 2008
Results First Submitted Date  ICMJE February 24, 2020
Results First Posted Date  ICMJE March 9, 2020
Last Update Posted Date March 9, 2020
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
Reduction in Episodic Oxygen Desaturation [ Time Frame: Concurrent ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2008)
  • Readmission [ Time Frame: 30 days post discharge ]
  • Length of Stay [ Time Frame: Concurrent ]
  • Visual Analog Scale of Shortness of Breath [ Time Frame: Concurrent ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Sleep Disordered Breathing In Acute Decompensated Heart Failure Patients
Official Title  ICMJE Apnea Rampant In Acute Decompensated Heart Failure II
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Sleep Apnea Syndromes
Intervention  ICMJE Device: Autotitrating Positive Airway Pressure
Patients will be treated with Autotitrating Positive Airway Pressure therapy
Study Arms  ICMJE
  • 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.
    Intervention: Device: Autotitrating Positive Airway Pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
6
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2008)
80
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00804349
Other Study ID Numbers  ICMJE HN-3025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Albert Einstein Healthcare Network
Study Sponsor  ICMJE Albert Einstein Healthcare Network
Collaborators  ICMJE Nexan Inc
Investigators  ICMJE
Principal Investigator: Darshak Karia, MD Albert Einstein Medical Center. Albert Einstein Healthcare Network
PRS Account Albert Einstein Healthcare Network
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP