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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rami Khayat, Ohio State University
ClinicalTrials.gov Identifier:
NCT00701519
First received: June 17, 2008
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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
Sleep Apnea
Congestive Heart Failure
Heart Failure,

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Prevalence of Sleep Disordered Breathing in Hospitalized Patients With Acutely Decompensated Heart Failure Syndrome

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • The risk and presence of sleep apnea in heart failure out patients. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Enrollment: 1600
Study Start Date: June 2007
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00701519

Locations
United States, Ohio
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
  More Information

Publications:

Responsible Party: Rami Khayat, Associate Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT00701519     History of Changes
Other Study ID Numbers: 2007H0055
Study First Received: June 17, 2008
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Apnea
Respiratory Aspiration
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014