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NCT Number: NCT00701038

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

.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

Treatment and study plan

auto adjusting bi-level positive airway pressure device

Device

auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.

Other names: APAP, CPAP

Primary outcomes

  1. Left Ventricular Ejection Fraction Improvement

    Time frame: baseline and again after three nights in hospital

    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.

Sponsors and collaborators

Lead sponsor

Rami Khayat

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2008
Registry last updated
Feb 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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