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Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rami Khayat, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00701038
First received: June 17, 2008
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

Congestive heart failure affects 2.3 percent 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 percent 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.


Condition Intervention
Sleep Apnea
Heart Failure
Device: auto adjusting bi-level positive airway pressure device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction Improvement [ Time Frame: baseline and again after three nights in hospital ] [ Designated as safety issue: No ]
    Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.


Enrollment: 54
Study Start Date: August 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device
Provided with an auto adjusting bi-level positive airway pressure device
Device: auto adjusting bi-level positive airway pressure device
auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
Other Names:
  • APAP
  • CPAP
No Intervention: Control
No device

Detailed Description:

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 continuous positive airway pressure (CPAP) is the most successful therapeutic modality available for obstructive sleep apnea. 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 congestive heart failure (CHF).

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

.Inclusion Criteria:

  • Able to provide an informed consent
  • Speaks English
  • Older than 21
  • Heart Failure
  • Positive for OSA

Exclusion Criteria:

  • CSA
  • Already on CPAP
  • Hemodynamic instability
  • Acute respiratory failure
  • Neurological defect
  • Dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701038

Sponsors and Collaborators
Rami Khayat
Investigators
Principal Investigator: Rami N Khayat, MD Ohio State University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rami Khayat, Associate Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT00701038     History of Changes
Other Study ID Numbers: 2005H0186
Study First Received: June 17, 2008
Results First Received: August 12, 2011
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Sleep apnea,
obstructive sleep apnea,
heart failure,
CHF

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

ClinicalTrials.gov processed this record on November 24, 2014