search
Back to results

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

Primary Purpose

Sleep Apnea, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
auto adjusting bi-level positive airway pressure device
Sponsored by
Rami Khayat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

.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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Device

    Control

    Arm Description

    Provided with an auto adjusting bi-level positive airway pressure device

    No device

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 17, 2008
    Last Updated
    January 29, 2013
    Sponsor
    Rami Khayat
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00701038
    Brief Title
    Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
    Official Title
    The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rami Khayat

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea, Heart Failure
    Keywords
    Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Device
    Arm Type
    Experimental
    Arm Description
    Provided with an auto adjusting bi-level positive airway pressure device
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No device
    Intervention Type
    Device
    Intervention Name(s)
    auto adjusting bi-level positive airway pressure device
    Other Intervention Name(s)
    APAP, CPAP
    Intervention Description
    auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
    Primary Outcome Measure Information:
    Title
    Left Ventricular Ejection Fraction Improvement
    Description
    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.
    Time Frame
    baseline and again after three nights in hospital

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rami N Khayat, MD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Heart Disease and Stroke-Statistics, American Heart Association, 2005 update
    Results Reference
    background
    PubMed Identifier
    9626176
    Citation
    Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
    Results Reference
    background
    PubMed Identifier
    10508793
    Citation
    Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med. 1999 Oct;160(4):1101-6. doi: 10.1164/ajrccm.160.4.9903020.
    Results Reference
    background
    PubMed Identifier
    15653964
    Citation
    Skinner MA, Choudhury MS, Homan SD, Cowan JO, Wilkins GT, Taylor DR. Accuracy of monitoring for sleep-related breathing disorders in the coronary care unit. Chest. 2005 Jan;127(1):66-71. doi: 10.1378/chest.127.1.66.
    Results Reference
    background
    PubMed Identifier
    10096933
    Citation
    Solin P, Bergin P, Richardson M, Kaye DM, Walters EH, Naughton MT. Influence of pulmonary capillary wedge pressure on central apnea in heart failure. Circulation. 1999 Mar 30;99(12):1574-9. doi: 10.1161/01.cir.99.12.1574.
    Results Reference
    background
    PubMed Identifier
    14597482
    Citation
    Mansfield DR, Gollogly NC, Kaye DM, Richardson M, Bergin P, Naughton MT. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6. doi: 10.1164/rccm.200306-752OC. Epub 2003 Nov 3.
    Results Reference
    background
    PubMed Identifier
    15781100
    Citation
    Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.
    Results Reference
    background
    PubMed Identifier
    9390980
    Citation
    Katragadda S, Xie A, Puleo D, Skatrud JB, Morgan BJ. Neural mechanism of the pressor response to obstructive and nonobstructive apnea. J Appl Physiol (1985). 1997 Dec;83(6):2048-54. doi: 10.1152/jappl.1997.83.6.2048.
    Results Reference
    background
    PubMed Identifier
    8365996
    Citation
    Morgan BJ, Denahan T, Ebert TJ. Neurocirculatory consequences of negative intrathoracic pressure vs. asphyxia during voluntary apnea. J Appl Physiol (1985). 1993 Jun;74(6):2969-75. doi: 10.1152/jappl.1993.74.6.2969.
    Results Reference
    background
    PubMed Identifier
    6613883
    Citation
    Magder SA, Lichtenstein S, Adelman AG. Effect of negative pleural pressure on left ventricular hemodynamics. Am J Cardiol. 1983 Sep 1;52(5):588-93. doi: 10.1016/0002-9149(83)90032-2.
    Results Reference
    background
    PubMed Identifier
    1559936
    Citation
    Stoohs R, Guilleminault C. Cardiovascular changes associated with obstructive sleep apnea syndrome. J Appl Physiol (1985). 1992 Feb;72(2):583-9. doi: 10.1152/jappl.1992.72.2.583.
    Results Reference
    background
    PubMed Identifier
    8498378
    Citation
    Hanly P, Sasson Z, Zuberi N, Lunn K. ST-segment depression during sleep in obstructive sleep apnea. Am J Cardiol. 1993 Jun 1;71(15):1341-5. doi: 10.1016/0002-9149(93)90552-n.
    Results Reference
    background
    PubMed Identifier
    15176689
    Citation
    Roebuck T, Solin P, Kaye DM, Bergin P, Bailey M, Naughton MT. Increased long-term mortality in heart failure due to sleep apnoea is not yet proven. Eur Respir J. 2004 May;23(5):735-40. doi: 10.1183/09031936.04.00060404.
    Results Reference
    background
    PubMed Identifier
    19567491
    Citation
    Khayat RN, Abraham WT, Patt B, Pu M, Jarjoura D. In-hospital treatment of obstructive sleep apnea during decompensation of heart failure. Chest. 2009 Oct;136(4):991-997. doi: 10.1378/chest.09-0597. Epub 2009 Jun 30.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs