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

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. Identifier: NCT00701519
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 16, 2017
Information provided by (Responsible Party):
Rami Khayat, Ohio State University

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
Sleep Apnea Congestive Heart Failure Heart Failure

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 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 : June 2007
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Primary Outcome Measures :
  1. The risk and presence of sleep apnea in heart failure out patients. [ Time Frame: Immediate ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every patient with heart failure at the OSU is offered the opportunity to receive free screening for sleep apnea.

Inclusion Criteria:

  • OSU Heart Failure Patient
  • Able to Complete Survey

Exclusion Criteria:

  • Neurological Deficit
  • No Heart failure
  • Less than 18 yrs old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701519

United States, Ohio
The Ohios State University
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Ohio State University
Principal Investigator: Rami N Khayat, MD The Ohio Sate University

1- Heart Disease and Stroke-Statistics, American Heart Association, 2005 update

Responsible Party: Rami Khayat, Associate Professor-Clinical, Ohio State University Identifier: NCT00701519     History of Changes
Other Study ID Numbers: 2007H0055
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rami Khayat, Ohio State University:
Sleep apnea,
Obstructive sleep apnea,
Heart failure

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes