An interventional study of auto adjusting bi-level positive airway pressure device in Sleep Apnea and Heart Failure, sponsored by Rami Khayat. Completed. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by Rami Khayat · Not applicable, Interventional, and Treatment
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.
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).
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Rami Khayat is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Provided with an auto adjusting bi-level positive airway pressure device
Device: auto adjusting bi-level positive airway pressure device
No device
auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
Also known as: APAP, CPAP
Left Ventricular Ejection Fraction Improvement
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.
Time frame: baseline and again after three nights in hospital
| Milestone | Device | Control |
|---|---|---|
| Started | 27 | 27 |
| Completed | 23 | 23 |
| Not completed | 4 | 4 |
| Withdrew: Study amended pilot group of patients | 4 | 4 |
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.
| percent change | Device | Control |
|---|---|---|
| Left Ventricular Ejection Fraction Improvement | 4.5 ± 1.7 | -.3 ± 1.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device | — | 0/27 (0%) | 0/27 (0%) |
| Control | — | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Device | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 14 | 37 |
| >=65 years | 4 | 13 | 17 |
| Age Continuous(years) | Device | Control | Total |
|---|---|---|---|
| Mean | 62 ± 14 | 51 ± 12 | 56 ± 14 |
| Sex: Female, Male(Participants) | Device | Control | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 20 | 19 | 39 |
| Region of Enrollment(participants) | Device | Control | Total |
|---|---|---|---|
| United States | 27 | 27 | 54 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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