The Prevalence of Sleep Disordered Breathing in Hospitalized Patients With Acutely Decompensated Heart Failure Syndrome

Sponsor
Ohio State University (Other)
Overall Status
Completed
CT.gov ID
NCT00701519
Collaborator
(none)
1,600
1
76
21

Study Details

Study Description

Brief Summary

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 CPAP is the most successful therapeutic modality available for OSA. 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 CHF.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Congestive heart failure affects 2.3% 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% 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.

    The significance of this question resides mainly in the best approach to diagnosis and treatment of SDB in this high risk and vulnerable population. Should every patient wit heart failure undergo a polysomnography to diagnose a highly likely underlying SDB, and trigger appropriate treatment? The cost of polysomnography and the access to sleep laboratory makes it almost prohibitive to pursue such an approach. An approach that combines evaluation of risk factors and an abbreviated portable study may be adequate and certainly less expensive. Our OSU- Sleep Heart program was established to deliver expedient diagnosis and treatment of SDB to patients with heart failure. In the published literature, there are not adequate data to guide the delivery of Sleep services in this patient population. Our program aims at targeting every heart failure patient with validated questionnaires and screening ambulatory sleep studies. The sensitivity and specificity of such a surveillance approach will need to be evaluated against the reference standard, the polysomnography. Therefore this protocol aims to evaluate the negative and positive predictive value of our clinical program.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Prevalence of Sleep Disordered Breathing in Hospitalized Patients With Acutely Decompensated Heart Failure Syndrome
    Study Start Date :
    Jun 1, 2007
    Actual Primary Completion Date :
    Oct 1, 2013
    Actual Study Completion Date :
    Oct 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. The risk and presence of sleep apnea in heart failure out patients. [Immediate]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • OSU Heart Failure Patient

    • Able to Complete Survey

    Exclusion Criteria:
    • Neurological Deficit

    • No Heart failure

    • Less than 18 yrs old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohios State University Columbus Ohio United States 43212

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    • Principal Investigator: Rami N Khayat, MD, The Ohio Sate University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rami Khayat, Associate Professor-Clinical, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT00701519
    Other Study ID Numbers:
    • 2007H0055
    First Posted:
    Jun 19, 2008
    Last Update Posted:
    Jan 16, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Rami Khayat, Associate Professor-Clinical, Ohio State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 16, 2017