Heart Failure, Sleep Apnea
Conditions
Keywords
Sleep apnea,, obstructive sleep apnea,, heart failure,, CHF
Brief 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.
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).
Interventions
DEVICEauto adjusting bi-level positive airway pressure device
auto adjusting bi-level positive airway pressure device is provided for treatment of obstructive sleep apnea.
Sponsors
Rami Khayat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction Improvement | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital | 27 |
| Control No auto adjusting bi-level positive airway pressure device given during hospital stay | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | study amended pilot group of patients | 4 | 4 |
Baseline characteristics
| Characteristic | Control | Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 4 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 23 Participants | 37 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 12 | 62 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 27 participants | 27 participants | 54 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
Primary
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
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device | Left Ventricular Ejection Fraction Improvement | 4.5 percent change | Standard Error 1.7 |
| Control | Left Ventricular Ejection Fraction Improvement | -.3 percent change | Standard Error 1.5 |