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

• Sponsor: Rami Khayat (Other)
• Overall Status: Completed
• CT.gov ID: NCT00701038
• Collaborator: (none)
• Enrollment: 54
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea; Heart Failure	Device: auto adjusting bi-level positive airway pressure device	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Role of Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

.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

Locations

No locations specified.

Sponsors and Collaborators

• Rami Khayat

Investigators

• Principal Investigator: Rami N Khayat, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hanly P, Sasson Z, Zuberi N, Lunn K. ST-segment depression during sleep in obstructive sleep apnea. Am J Cardiol. 1993 Jun 1;71(15):1341-5.
• Heart Disease and Stroke-Statistics, American Heart Association, 2005 update
• Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9.
• Katragadda S, Xie A, Puleo D, Skatrud JB, Morgan BJ. Neural mechanism of the pressor response to obstructive and nonobstructive apnea. J Appl Physiol (1985). 1997 Dec;83(6):2048-54.
• Magder SA, Lichtenstein S, Adelman AG. Effect of negative pleural pressure on left ventricular hemodynamics. Am J Cardiol. 1983 Sep 1;52(5):588-93.
• Mansfield DR, Gollogly NC, Kaye DM, Richardson M, Bergin P, Naughton MT. Controlled trial of continuous positive airway pressure in obstructive sleep apnea and heart failure. Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6. Epub 2003 Nov 3.
• Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.
• Morgan BJ, Denahan T, Ebert TJ. Neurocirculatory consequences of negative intrathoracic pressure vs. asphyxia during voluntary apnea. J Appl Physiol (1985). 1993 Jun;74(6):2969-75.
• Roebuck T, Solin P, Kaye DM, Bergin P, Bailey M, Naughton MT. Increased long-term mortality in heart failure due to sleep apnoea is not yet proven. Eur Respir J. 2004 May;23(5):735-40.
• Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med. 1999 Oct;160(4):1101-6.
• Skinner MA, Choudhury MS, Homan SD, Cowan JO, Wilkins GT, Taylor DR. Accuracy of monitoring for sleep-related breathing disorders in the coronary care unit. Chest. 2005 Jan;127(1):66-71.
• Solin P, Bergin P, Richardson M, Kaye DM, Walters EH, Naughton MT. Influence of pulmonary capillary wedge pressure on central apnea in heart failure. Circulation. 1999 Mar 30;99(12):1574-9.
• Stoohs R, Guilleminault C. Cardiovascular changes associated with obstructive sleep apnea syndrome. J Appl Physiol (1985). 1992 Feb;72(2):583-9.

• Responsible Party: Rami Khayat, Associate Professor-Clinical, Ohio State University
• ClinicalTrials.gov Identifier: NCT00701038
• Other Study ID Numbers: 2005H0186
• First Posted: Jun 19, 2008
• Last Update Posted: Feb 4, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Rami Khayat, Associate Professor-Clinical, Ohio State University: Sleep apnea,; obstructive sleep apnea,; heart failure,; CHF
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Heart Failure

Study Results

Participant Flow

Arm/Group Title	Device	Control
Arm/Group Description	Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital	No auto adjusting bi-level positive airway pressure device given during hospital stay
Period Title: Overall Study
STARTED	27	27
COMPLETED	23	23
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Device	Control	Total
Arm/Group Description	Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital	No auto adjusting bi-level positive airway pressure device given during hospital stay	Total of all reporting groups
Overall Participants	27	27	54
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 85.2%	14 51.9%	37 68.5%
>=65 years	4 14.8%	13 48.1%	17 31.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62 (14)	51 (12)	56 (14)
Sex: Female, Male (Count of Participants)
Female	7 25.9%	8 29.6%	15 27.8%
Male	20 74.1%	19 70.4%	39 72.2%
Region of Enrollment (participants) [Number]
United States	27 100%	27 100%	54 100%

Outcome Measures

1. Primary Outcome

Title	Left Ventricular Ejection Fraction Improvement
Description	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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Device	Control
Arm/Group Description	Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital	No auto adjusting bi-level positive airway pressure device given during hospital stay
Measure Participants	23	23
Mean (Standard Error) [percent change]	4.5 (1.7)	-.3 (1.5)

Adverse Events

Arm/Group Title	Device		Control
Arm/Group Description	Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital		No auto adjusting bi-level positive airway pressure device given during hospital stay
All Cause Mortality
	Device		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Device		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Device		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.