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The Prevalence and Risk Factors of Sleep Disordered Breathing in a Heart Failure Program

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ClinicalTrials.gov Identifier: NCT00679822
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Rami Khayat, Ohio State University

Brief Summary:

The objective of this protocol is the evaluation of our clinical screening program for sleep disorders in patients with heart failure.

These patients have very high prevalence of Sleep Disordered Breathing (SDB), including central and obstructive sleep apnea. There is also strong evidence that SDB, if unrecognized and untreated, will worsen heart failure and may leads to serious complications. Effective treatment of SDB results in improvement in heart failure and functional status. So far there are no guidelines in the area of screening in this patient population. The only test that would reliably rule out or confirm SDB is the polysomnography (PSG) this test is expensive and technically demanding. With the current approach to diagnosis and treatment of SDB, it routinely takes up to 5-6 months between the emergence of clinical suspicion of SDB and the initiation of appropriate treatment with CPAP. This delay and cost of this traditional approach, is a significant obstacle to providing highly needed care to this very vulnerable population.

In OSU we have a state of the art Heart Failure Program and a Sleep Heart program that was created to develop an approach to prompt diagnosis and treatment of SDB in our heart failure patients. We designed an algorithm that employs validated questionnaires and FDA approved devices. We need, however to validate our algorithm against the gold standard: the PSG. Furthermore, we need to analyze the prevalence and risk factors of each sleep disorder in light of the recent changes in the management of heart failure, which may have influenced the risk factors and prevalence as we knew them. This protocol includes a combination of clinically indicated procedures, and others that are repeated for validation purposes. The accumulation and analysis of data is also done for research purposes.


Condition or disease
Sleep Apnea Heart Failure

Detailed Description:

Patients with systolic heart failure have higher prevalence of SDB than the general middle aged population [1-3]. There is strong evidence that treatment of OSA in the general population reduces fatal and non-fatal cardiovascular events[4]. In patients with underlying heart failure and OSA, treatment with CPAP improves ejection fraction and functional outcome[5]. In patients with heart failure and CSA, there is evidence of increased sympathetic activity [6], predisposition to dsyrrythmia [7] and increased mortality. However, to date systematic diagnostic approach of SDB in this vulnerable population is not part of the guidelines for management of heart failure.

In patients with heart failure, the prevalence of Obstructive Sleep Apnea (OSA) was estimated at 24-37 % and Central Sleep Apnea (CSA) at 40%. The severity of CSA is shown to be directly related to the severity of the underlying heart failure[8]. Additionally, the management of heart failure has changed significantly since these original studies, to include b-blockade, aggressive hemodynamic targets, and device therapy[9]. Taken together, these observations call into question the applicability of this previous prevalence estimate of CSA in this patient population. Indeed, recent data suggest a decline in the incidence of CSA[10, 11]. Obstructive Sleep Apnea, on the other hand, is strongly associated with obesity. The rising incidence of obesity, and its strong association with cardiovascular disease, may suggest a rise in the incidence of OSA in this patient population.

Did the recent changes in the management of heart failure change the prevalence and distribution of SDB? What is the most effective approach to diagnosis of this highly prevalent disorder in this very vulnerable patient population? A modern cost benefit analysis and comparison against the current slow inefficient and very expensive approach is needed. An approach that combines evaluation of risk factors and an abbreviated portable study may be adequate and certainly less expensive. Our program aims at providing every heart failure patient with clinically indicating and not otherwise available screening for SDB. Validated questionnaires and screening ambulatory sleep studies are provided to every patient. Additionally, this clinical operation has no risk to patients, rather a significant benefit. The sensitivity and specificity of this surveillance approach will need to be evaluated and validated. The validation operation will bring additional benefit to our future patients. The accumulation and analysis of the data will also enable us to determine the magnitude of the sleep co-morbidity in our heart failure patients and help educate clinicians who treat similar patients nationwide


Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Case-Only
Official Title: The Prevalence and Risk Factors of Sleep Disordered Breathing in a Heart Failure Program
Study Start Date : June 2007
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort
Heart Failure
Heart Failure Out Patients at OSU



Primary Outcome Measures :
  1. Validation of Inpatient Portable Sleep Study [ Time Frame: Baseline ]
    Patients at risk of Sleep Disordered Breathing with heart failure are administered a portable sleep study during their hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Out-patients at OSU's Heart Failure clinics
Criteria

Inclusion Criteria:

  • OSU Heart Failure Patient
  • Willingness to complete survey
  • Willingness to complete take home sleep study

Exclusion Criteria:

  • Neurological deficit
  • Less than 18yrs 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 ClinicalTrials.gov identifier (NCT number): NCT00679822


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

Publications:

Responsible Party: Rami Khayat, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00679822     History of Changes
Other Study ID Numbers: 2007H0043
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014

Keywords provided by Rami Khayat, Ohio State University:
OSA
sleep apnea
heart failure
CHF
heart clinic
clinic
obstructive sleep apnea

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