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

NCT ID: NCT00701519

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Sleep Apnea; Congestive Heart Failure; Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• OSU Heart Failure Patient
• Able to Complete Survey

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Rami Khayat

Associate Professor-Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rami N Khayat, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio Sate University

Locations

The Ohios State University

Columbus, Ohio, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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Other Identifiers

2007H0055

Identifier Type: -

Identifier Source: org_study_id