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N/A N=54 Randomized Treatment

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

Sleep Apnea · Heart Failure

Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Left Ventricular Ejection Fraction Improvement — 4.5; -.3 percent change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
auto adjusting bi-level positive airway pressure device (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Rami Khayat
Primary completion
Aug 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Left Ventricular Ejection Fraction Improvement
4.5; -.3

Summary

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00701038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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